Trial · NCT02710526
Phase II Pharmacokinetics Study of CAM2038
NCT02710526, Phase 2, Completed, Braeburn Pharmaceuticals; results first posted 2020-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Pharmacokinetics Study of CAM2038. Trials, record NCT02710526. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02710526
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Pharmacokinetics Study of CAM2038
- NCT number
- NCT02710526
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Braeburn Pharmaceuticals
- Conditions
- Opioid Use Disorder, Chronic Pain
- Interventions
- CAM2038
- First posted
- 2016-03-16
- Last updated
- 2020-04-30
- Results first posted
- 2020-04-30
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population |
| Primary | Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population |
| Primary | Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine |
| Primary | Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Tss,max (time to maximum concentration at steady state) for each injection site-buprenorphine |
| Primary | Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Buprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Buprenorphine for Pharmacokinetic Population |
| Primary | Average Steady State Concentration-Buprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Average steady state concentration-Buprenorphine-Pharmacokinetic Population |
| Primary | Maximum Steady State Concentration-Buprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Maximum steady state concentration-BuprenorphinePharmacokinetic (PK) Population |
| Primary | Time to Maximum Concentration at Steady State-Buprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Time to maximum concentration at steady state-Buprenorphine Pharmacokinetic (PK) Population |
| Primary | Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Norbuprenorphine/buprenorphine ratios at maximum concentration at steady state Evaluable Pharmacokinetic (PKEVAL) Population |
| Primary | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm. | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Norbuprenorphine Evaluable Pharmacokinetic (PKEVAL) Population |
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 | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest. | ng*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest | h | MEDIAN |
| PRIMARY | Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Buprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data. | ng*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Average Steady State Concentration-Buprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Steady State Concentration-Buprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Time to Maximum Concentration at Steady State-Buprenorphine | PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 | Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data. | h | MEDIAN |
| PRIMARY | Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest | ratio | GEOMETRIC_MEAN |
| PRIMARY | AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm. | PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. | Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest | ng*h/mL | GEOMETRIC_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group320
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population | 32 mg CAM2038 Weekly-Buttock | 700 | Geometric Coefficient of Variation 27.1 | ng*h/mL | |
AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population | 32 mg CAM2038 Weekly-Abdomen | 657 | Geometric Coefficient of Variation 27.2 | ng*h/mL | |
AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population | 32 mg CAM2038 Weekly-Thigh | 613 | Geometric Coefficient of Variation 36.8 | ng*h/mL | |
AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population | 32 mg CAM2038 Weekly-Upper Arm | 591 | Geometric Coefficient of Variation 33.7 | ng*h/mL | |
| Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population | 32 mg CAM2038 Weekly-Buttock | 4.17 | Geometric Coefficient of Variation 27.1 | ng/mL | |
| Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population | 32 mg CAM2038 Weekly-Abdomen | 3.91 | Geometric Coefficient of Variation 27.2 | ng/mL | |
| Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population | 32 mg CAM2038 Weekly-Thigh | 3.65 | Geometric Coefficient of Variation 36.8 | ng/mL | |
| Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population | 32 mg CAM2038 Weekly-Upper Arm | 3.52 | Geometric Coefficient of Variation 33.7 | ng/mL | |
| Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | 32 mg CAM2038 Weekly-Buttock | 6.87 | Geometric Coefficient of Variation 37.2 | ng/mL | |
| Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. | 32 mg CAM2038 Weekly-Abdomen | 6.56 | Geometric Coefficient of Variation 29.9 | ng/mL |
1 to 10 of 320Source ClinicalTrials.gov
See all 320 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase | STARTED | 32 mg CAM2038 Weekly | 28 | |
| Treatment Phase | STARTED | 128 mg CAM2038 Monthly Injection | 20 | |
| Treatment Phase | STARTED | 160 mg CAM2038 Monthly Injection | 18 | |
| Treatment Phase | COMPLETED | 32 mg CAM2038 Weekly | 22 | |
| Treatment Phase | COMPLETED | 128 mg CAM2038 Monthly Injection | 16 | |
| Treatment Phase | COMPLETED | 160 mg CAM2038 Monthly Injection | 12 | |
| Treatment Phase | NOT COMPLETED | 32 mg CAM2038 Weekly | 6 | |
| Treatment Phase | NOT COMPLETED | 128 mg CAM2038 Monthly Injection | 4 | |
| Treatment Phase | NOT COMPLETED | 160 mg CAM2038 Monthly Injection | 6 | |
| Safety Extension | STARTED | 32 mg CAM2038 Weekly | 15 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events132
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 | Atrial Fibrillation | Cardiac disorders | 32 mg CAM2038 Weekly | 0 | 28 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | 128 mg CAM2038 Monthly Injection | 1 | 20 | 1 |
| other | Atrial Fibrillation | Cardiac disorders | 160 mg CAM2038 Monthly Injection | 0 | 17 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | 24 mg SL BPN | 0 | 18 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | 32 mg CAM2038 Weekly | 0 | 28 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | 128 mg CAM2038 Monthly Injection | 1 | 20 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | 160 mg CAM2038 Monthly Injection | 0 | 17 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | 24 mg SL BPN | 0 | 18 | 0 |
| other | Constipation | Gastrointestinal disorders | 32 mg CAM2038 Weekly | 1 | 28 | 1 |
| other | Constipation | Gastrointestinal disorders | 128 mg CAM2038 Monthly Injection | 0 | 20 | 0 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 32 mg CAM2038 Weekly | 0 | 28 |
| Total, all-cause mortality | 128 mg CAM2038 Monthly Injection | 0 | 20 |
| Total, all-cause mortality | 160 mg CAM2038 Monthly Injection | 0 | 17 |
| Total, all-cause mortality | 24 mg SL BPN | 0 | 18 |
| Total, other adverse events | 32 mg CAM2038 Weekly | 16 | 28 |
| Total, other adverse events | 128 mg CAM2038 Monthly Injection | 18 | 20 |
| Total, other adverse events | 160 mg CAM2038 Monthly Injection | 17 | 17 |
| Total, other adverse events | 24 mg SL BPN | 0 | 18 |
| Total, serious adverse events | 32 mg CAM2038 Weekly | 0 | 28 |
| Total, serious adverse events | 128 mg CAM2038 Monthly Injection | 0 | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37584841 | DERIVED |
Source PubMed
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.
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