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Buprenorphine Disposition and CYP3A

NCT01576575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-01-22

Study results available
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Summary

To evaluate role of CYP3A in buprenorphine disposition and effect

Conditions

  • Healthy

Interventions

DRUG

Buprenorphine Control

Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)

DRUG

Buprenorphine + Rifampin

Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine

DRUG

Buprenorphine + Grapefruit juice

Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine

DRUG

Buprenorphine + Ketoconazole

Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Evan Kharasch, MD, PhD · Washington University School of Medicine

Study Design

Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-03-29
Completion
2014-03-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01576575 on ClinicalTrials.gov