N/A
N=21
Buprenorphine Disposition and CYP3A
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01576575 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Plasma Cmax of Buprenorphine
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Buprenorphine Control (Drug); Buprenorphine + Rifampin (Drug); Buprenorphine + Grapefruit juice (Drug); Buprenorphine + Ketoconazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Cmax of Buprenorphine |
— | — |
Summary
To evaluate role of CYP3A in buprenorphine disposition and effect
Eligibility Criteria
Inclusion Criteria
Each subject must meet all of the following criteria:
- Male or non-pregnant female volunteer, 18-50 yr old
- Good general health with no known major medical conditions
- BMI < 33
- Provide informed consent
Exclusion Criteria
Subjects will not be enrolled if any of the following criteria exist:
- Known history of liver or kidney disease
- Use of prescription or non-prescription medications, herbals or foods known to be metabolized by or affect CYP3A activity (this includes the use of oral contraceptives).
- Females who are pregnant or nursing
- Known history of drug or alcohol addiction (prior or present addiction or addiction treatment)
- Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential)
Data sourced from ClinicalTrials.gov (NCT01576575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.