Trial · NCT04020016
Study of Nalbuphine ER in Participants With Hepatic Impairment
NCT04020016, Phase 1, Completed, Trevi Therapeutics; results first posted 2026-03-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Nalbuphine ER in Participants With Hepatic Impairment. Trials, record NCT04020016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04020016
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Nalbuphine ER in Participants With Hepatic Impairment
- NCT number
- NCT04020016
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 28 participants, actual
- Lead sponsor
- Trevi Therapeutics
- Conditions
- Hepatic Impairment
- Interventions
- Nalbuphine ER
- First posted
- 2019-07-15
- Last updated
- 2026-03-19
- Results first posted
- 2026-03-19
- Limitations and caveats
- As per the judgement of the safety committee, the Part 2 (MAD) was not conducted based on protocol defined criteria.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | |
| Primary | Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | |
| Primary | Part 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | |
| Primary | Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | |
| Primary | Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | |
| Primary | Part 1: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE) | From signing the informed consent form up to Day 4 | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE was defined as any AE that occurs after the first dose of study drug. TEAEs included both serious and non-serious TEAEs. |
| Primary | Part 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | From signing the informed consent form up to Day 4 | The clinical laboratory parameters included the clinical chemistry, hematology, coagulation, and urinalysis. Clinical significance was determined by the investigator. |
| Primary | Part 1: Number of Participants With Clinically Significant Findings in Vital Sign Parameters | From signing the informed consent form up to Day 4 | Vital signs measurements included diastolic and systolic blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator. |
| Primary | Part 1: Number of Participants With Clinically Significant Findings in Physical Examination Parameters | From signing the informed consent form up to Day 4 | Physical examination included examination of at least the following components: head, eyes, ears, nose, throat (HEENT), neck, lungs, abdomen, skin, cardiovascular and musculoskeletal evaluation, and general neurological examination. Clinical significance was determined by the investigator. |
| Primary | Part 1: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) | From signing the informed consent form up to Day 4 | ECG data included the measurement of heart rate and aggregate PR interval, QRS duration, QT interval, QTcB interval, and QTcF interval. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Number analyzed indicates number of participants who were evaluable for this outcome measure in a particular group. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Number analyzed indicates number of participants who were evaluable for this outcome measure in a particular group. | hours (h) | MEDIAN |
| PRIMARY | Part 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Overall number of participants analyzed is the number of participants with evaluable data for this outcome measure. Number analyzed indicates number of participants who were evaluable in a particular group. | h | MEDIAN |
| PRIMARY | Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Overall number of participants analyzed is the number of participants with evaluable data for this outcome measure. Number analyzed indicates number of participants who were evaluable in a particular group. | hour-nanogram per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER | Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level | PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Number analyzed indicates number of participants who were evaluable for this outcome measure in a particular group. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE) | From signing the informed consent form up to Day 4 | Safety analysis set (SAS) included all enrolled participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | From signing the informed consent form up to Day 4 | SAS included all enrolled participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Clinically Significant Findings in Vital Sign Parameters | From signing the informed consent form up to Day 4 | SAS included all enrolled participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Clinically Significant Findings in Physical Examination Parameters | From signing the informed consent form up to Day 4 | SAS included all enrolled participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) | From signing the informed consent form up to Day 4 | SAS included all enrolled participants who had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Cohort 1: NAL ER 27 mg | Mild Hepatic Impairment (Group 1) | 3.30 | Geometric Coefficient of Variation 41.8 | nanogram per milliliter (ng/mL) |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Cohort 2: NAL ER 54 mg | Mild Hepatic Impairment (Group 1) | 7.67 | Geometric Coefficient of Variation 38.9 | nanogram per milliliter (ng/mL) |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Cohort 3: NAL ER 108 mg | Mild Hepatic Impairment (Group 1) | 13.9 | Geometric Coefficient of Variation 34.1 | nanogram per milliliter (ng/mL) |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Cohort 4: NAL ER 162 mg | Mild Hepatic Impairment (Group 1) | 18.7 | Geometric Coefficient of Variation 34.9 | nanogram per milliliter (ng/mL) |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Cohort 1: NAL ER 27 mg | Moderate Hepatic Impairment (Group 2) | 10.9 | Geometric Coefficient of Variation 77.9 | nanogram per milliliter (ng/mL) |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Cohort 2: NAL ER 54 mg | Moderate Hepatic Impairment (Group 2) | 22.3 | Geometric Coefficient of Variation 70.7 | nanogram per milliliter (ng/mL) |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Cohort 3: NAL ER 108 mg | Moderate Hepatic Impairment (Group 2) | 42.4 | Geometric Coefficient of Variation 52.2 | nanogram per milliliter (ng/mL) |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Cohort 4: NAL ER 162 mg | Moderate Hepatic Impairment (Group 2) | 57.2 | Geometric Coefficient of Variation 55.3 | nanogram per milliliter (ng/mL) |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Cohort 1: NAL ER 27 mg | Severe Hepatic Impairment (Group 3) | 27.7 | Geometric Coefficient of Variation 21.9 | nanogram per milliliter (ng/mL) |
| Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER | Cohort 5: NAL ER 162 mg | No Hepatic Impairment (Group 4) | 25.7 | Geometric Coefficient of Variation 34.2 | nanogram per milliliter (ng/mL) |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cohort 1 | STARTED | Cohort 1: NAL ER 27 mg | 16 | |
| Cohort 1 | STARTED | Cohort 2: NAL ER 54 mg | 0 | |
| Cohort 1 | STARTED | Cohort 3: NAL ER 108 mg | 0 | |
| Cohort 1 | STARTED | Cohort 4: NAL ER 162 mg | 0 | |
| Cohort 1 | STARTED | Cohort 5: NAL ER 162 mg | 0 | |
| Cohort 1 | COMPLETED | Cohort 1: NAL ER 27 mg | 16 | |
| Cohort 1 | COMPLETED | Cohort 2: NAL ER 54 mg | 0 | |
| Cohort 1 | COMPLETED | Cohort 3: NAL ER 108 mg | 0 | |
| Cohort 1 | COMPLETED | Cohort 4: NAL ER 162 mg | 0 | |
| Cohort 1 | COMPLETED | Cohort 5: NAL ER 162 mg | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events75
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 | Vomiting | Gastrointestinal disorders | Cohort 1: NAL ER 27 mg | 2 | 16 | |
| other | Vomiting | Gastrointestinal disorders | Cohort 2: NAL ER 54 mg | 1 | 15 | |
| other | Vomiting | Gastrointestinal disorders | Cohort 3: NAL ER 108 mg | 0 | 15 | |
| other | Vomiting | Gastrointestinal disorders | Cohort 4: NAL ER 162 mg | 1 | 13 | |
| other | Vomiting | Gastrointestinal disorders | Cohort 5: NAL ER 162 mg | 3 | 8 | |
| other | Nausea | Gastrointestinal disorders | Cohort 1: NAL ER 27 mg | 1 | 16 | |
| other | Nausea | Gastrointestinal disorders | Cohort 2: NAL ER 54 mg | 0 | 15 | |
| other | Nausea | Gastrointestinal disorders | Cohort 3: NAL ER 108 mg | 1 | 15 | |
| other | Nausea | Gastrointestinal disorders | Cohort 4: NAL ER 162 mg | 0 | 13 | |
| other | Nausea | Gastrointestinal disorders | Cohort 5: NAL ER 162 mg | 1 | 8 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: NAL ER 27 mg | 0 | 16 |
| Total, all-cause mortality | Cohort 2: NAL ER 54 mg | 0 | 15 |
| Total, all-cause mortality | Cohort 3: NAL ER 108 mg | 0 | 15 |
| Total, all-cause mortality | Cohort 4: NAL ER 162 mg | 0 | 13 |
| Total, all-cause mortality | Cohort 5: NAL ER 162 mg | 0 | 8 |
| Total, other adverse events | Cohort 1: NAL ER 27 mg | 3 | 16 |
| Total, other adverse events | Cohort 2: NAL ER 54 mg | 5 | 15 |
| Total, other adverse events | Cohort 3: NAL ER 108 mg | 9 | 15 |
| Total, other adverse events | Cohort 4: NAL ER 162 mg | 12 | 13 |
| Total, other adverse events | Cohort 5: NAL ER 162 mg | 5 | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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