Trial · NCT04447287
A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder
NCT04447287, Phase 1, Completed, Astellas Pharma Global Development, Inc.; results first posted 2022-01-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder. Trials, record NCT04447287. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04447287
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder
- NCT number
- NCT04447287
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 23 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Opioid Use Disorder
- Interventions
- ASP8062, Placebo ASP8062, buprenorphine/naloxone
- First posted
- 2020-06-25
- Last updated
- 2024-11-21
- Results first posted
- 2022-01-12
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | From first dose of study drug up to end of study visit (up to day 27) | An AE is defined as any untoward medical occurrence in a participant administered an Investigational Product (IP) and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of IP whether or not considered related to the IP. A treatment-emergent adverse event (TEAE) was defined as an AE with onset at any time from first dosing until last scheduled procedure. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization. |
| Primary | Number of Participants With Suicidal Ideation and/or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to day 27 | The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) were reported. |
| Primary | Change From Baseline in Blood Oxygen Saturation (SpO2) at Predose | 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12 | The blood oxygen saturation (SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose. |
| Primary | Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose | 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12 | The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose. |
| Primary | Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose | 'buprenorphine/naloxone': Baseline and 2 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 2 hour postdose Day 12 | The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose. |
| Primary | Change From Baseline in Blood Oxygen Saturation (SpO2) at 4 Hour Postdose | 'buprenorphine/naloxone': Baseline and 4 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 4 hour postdose Day 12 | The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose. |
| Primary | Change From Baseline in Blood Oxygen Saturation (SpO2) at 8 Hour Postdose | 'buprenorphine/naloxone': Baseline and 8 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 8 hour postdose Day 12 | The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose. |
| Primary | Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose | 'buprenorphine/naloxone': Baseline and 12 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 12 hour postdose Day 12 | The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose. |
| Primary | Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose | 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and predose Day 12 | End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. |
| Primary | Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose | 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12 | End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | From first dose of study drug up to end of study visit (up to day 27) | The analysis population was the Safety Analysis Set (SAF), which consisted of all participants who received at least 1 dose of ASP8062. | Participants | NUMBER |
| PRIMARY | Number of Participants With Suicidal Ideation and/or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to day 27 | The analysis population was the SAF, which consisted of all participants who received at least 1 dose of Investigational Product (IP). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Blood Oxygen Saturation (SpO2) at Predose | 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12 | The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure. | Percentage of oxygen saturation | MEAN |
| PRIMARY | Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose | 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12 | The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure. | Percentage of oxygen saturation | MEAN |
| PRIMARY | Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose | 'buprenorphine/naloxone': Baseline and 2 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 2 hour postdose Day 12 | The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure. | Percentage of oxygen saturation | MEAN |
| PRIMARY | Change From Baseline in Blood Oxygen Saturation (SpO2) at 4 Hour Postdose | 'buprenorphine/naloxone': Baseline and 4 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 4 hour postdose Day 12 | The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure. | Percentage of oxygen saturation | MEAN |
| PRIMARY | Change From Baseline in Blood Oxygen Saturation (SpO2) at 8 Hour Postdose | 'buprenorphine/naloxone': Baseline and 8 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 8 hour postdose Day 12 | The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure. | Percentage of oxygen saturation | MEAN |
| PRIMARY | Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose | 'buprenorphine/naloxone': Baseline and 12 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 12 hour postdose Day 12 | The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure. | Percentage of oxygen saturation | MEAN |
| PRIMARY | Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose | 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and predose Day 12 | The analysis population was the Safety Analysis Set (SAF), which consisted of all participants who received at least 1 dose of ASP8062. It was pre-specified to assess only the Investigational Period Arms/Groups for this Outcome Measure. | mmHg | MEAN |
| PRIMARY | Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose | 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12 | The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure. | mmHg | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group103
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | Buprenorphine/Naloxone (Run-in Period) | TEAE | 16 | Participants | |
| Number of Participants With Adverse Events (AEs) | ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | TEAE | 6 | Participants | |
| Number of Participants With Adverse Events (AEs) | ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | TEAE | 7 | Participants | |
| Number of Participants With Adverse Events (AEs) | Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | TEAE | 6 | Participants | |
| Number of Participants With Adverse Events (AEs) | Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | TEAE | 2 | Participants | |
| Number of Participants With Adverse Events (AEs) | Buprenorphine/Naloxone (Run-in Period) | Drug-Related TEAE | 12 | Participants | |
| Number of Participants With Adverse Events (AEs) | ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | Drug-Related TEAE | 6 | Participants | |
| Number of Participants With Adverse Events (AEs) | ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | Drug-Related TEAE | 5 | Participants | |
| Number of Participants With Adverse Events (AEs) | Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | Drug-Related TEAE | 6 | Participants | |
| Number of Participants With Adverse Events (AEs) | Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | Drug-Related TEAE | 1 | Participants |
1 to 10 of 103Source ClinicalTrials.gov
See all 103 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Run-in Period | STARTED | Buprenorphine/Naloxone | 23 | |
| Period 1: Run-in Period | STARTED | ASP8062 in Combination With Buprenorphine/Naloxone | 0 | |
| Period 1: Run-in Period | STARTED | Placebo ASP8062 in Combination With Buprenorphine/Naloxone | 0 | |
| Period 1: Run-in Period | COMPLETED | Buprenorphine/Naloxone | 19 | |
| Period 1: Run-in Period | COMPLETED | ASP8062 in Combination With Buprenorphine/Naloxone | 0 | |
| Period 1: Run-in Period | COMPLETED | Placebo ASP8062 in Combination With Buprenorphine/Naloxone | 0 | |
| Period 1: Run-in Period | NOT COMPLETED | Buprenorphine/Naloxone | 4 | |
| Period 1: Run-in Period | NOT COMPLETED | ASP8062 in Combination With Buprenorphine/Naloxone | 0 | |
| Period 1: Run-in Period | NOT COMPLETED | Placebo ASP8062 in Combination With Buprenorphine/Naloxone | 0 | |
| Period 2: Investigational Period | STARTED | Buprenorphine/Naloxone | 1 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events115
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Buprenorphine/Naloxone | 4 | 23 | 4 |
| other | Constipation | Gastrointestinal disorders | ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 0 | 12 | 0 |
| other | Constipation | Gastrointestinal disorders | ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | 0 | 12 | 0 |
| other | Constipation | Gastrointestinal disorders | Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 2 | 6 | 2 |
| other | Constipation | Gastrointestinal disorders | Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | 0 | 6 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Buprenorphine/Naloxone | 0 | 23 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 0 | 12 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | 1 | 12 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 1 | 6 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | 0 | 6 | 0 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buprenorphine/Naloxone | 0 | 23 |
| Total, all-cause mortality | ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 0 | 12 |
| Total, all-cause mortality | ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | 0 | 12 |
| Total, all-cause mortality | Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 0 | 6 |
| Total, all-cause mortality | Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | 0 | 6 |
| Total, other adverse events | Buprenorphine/Naloxone | 16 | 23 |
| Total, other adverse events | ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 6 | 12 |
| Total, other adverse events | ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | 7 | 12 |
| Total, other adverse events | Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period) | 6 | 6 |
| Total, other adverse events | Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period) | 2 | 6 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36738100 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UG3DA051392 | Evaluation of the Safety and Efficacy of a New Oral Small Molecule GABA-B Receptor Positive Allosteric Modulator (PAM) as an Add-on Maintenance Therapy for Opioid Use Disorder (OUD) | ERDMAN, JAY; MAREK, GERARD JOSEPH | ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC. | NATIONAL INSTITUTE ON DRUG ABUSE | 2020 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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