An interventional study of Buprenorphine Control and Buprenorphine + Rifampin in Healthy, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Other
To evaluate role of CYP3A in buprenorphine disposition and effect
Subjects will be studied during a maximum of seven occasions.
Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual buprenorphine (2-4 mg), with 1-3 week washout between sessions.
Sessions 1\&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)
Sessions 3\&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine
Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine
Sessions 6\&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine
Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 271 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.
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Each subject must meet all of the following criteria:
Exclusion Criteria:
Subjects will not be enrolled if any of the following criteria exist:
Subjects will be studied during a maximum of seven occasions. Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual buprenorphine (2-4 mg), with 1-3 week washout between sessions. Sessions 1\&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV) Sessions 3\&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine Sessions 6\&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine
Drug: Buprenorphine Control · Drug: Buprenorphine + Rifampin · Drug: Buprenorphine + Grapefruit juice · Drug: Buprenorphine + Ketoconazole
Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)
Drug pages: Buprenorphine · Rifampin
Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine
Drug pages: Buprenorphine · Grapefruit juice
Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine
Drug pages: Buprenorphine · Ketoconazole
Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine
Plasma Cmax of Buprenorphine
Time frame: 96 hr
| Milestone | Healthy Volunteers |
|---|---|
| Started | 21 |
| Completed | 18 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 3 |
| Milestone | Healthy Volunteers |
|---|---|
| Started | 18 |
| Completed | 15 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 3 |
| Milestone | Healthy Volunteers |
|---|---|
| Started | 15 |
| Completed | 14 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | Healthy Volunteers |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
No measurements were reported for this outcome.
Collected over Up to 96 hours following dosing. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control (no Pretreatment) | 0/21 (0%) | 0/21 (0%) | 21/21 (100%) |
| Liver and Gut CYP3A Induction | 0/18 (0%) | 0/18 (0%) | 15/18 (83.3%) |
| Gut Only CYP3A Inhibition | 0/14 (0%) | 0/14 (0%) | 14/14 (100%) |
| Liver and Gut CYP3A Inhibition | 0/13 (0%) | 0/13 (0%) | 13/13 (100%) |
| Event | Control (no Pretreatment) | Liver and Gut CYP3A Induction | Gut Only CYP3A Inhibition | Liver and Gut CYP3A Inhibition |
|---|---|---|---|---|
| nauseaGastrointestinal disorders | 12/21 | 13/18 | 11/14 | 12/13 |
| itchGeneral disorders | 14/21 | 10/18 | 11/14 | 8/13 |
| HeadacheNervous system disorders | 4/21 | 2/18 | 3/14 | 5/13 |
| DizzynessNervous system disorders | 4/21 | 3/18 | 1/14 | 1/13 |
| Age, Continuous(years) | Healthy Volunteers |
|---|---|
| Mean | 27 ± 8 |
| Sex: Female, Male(Participants) | Healthy Volunteers |
|---|---|
| Female | 8 |
| Male | 13 |
The record gives a start of Jun 2010, a primary completion of Mar 2014 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2020, 5 years 9 months after primary completion.
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Buprenorphine · Rifampin · Grapefruit juice · Ketoconazole
Washington University School of Medicine →