NCT01648270

Brief Summary

The determine the effect of cyclosporine on buprenorphine disposition

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

January 22, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

4.7 years

First QC Date

April 10, 2012

Results QC Date

June 20, 2018

Last Update Submit

January 8, 2020

Conditions

Healthy

Keywords

buprenorphineCYP3A

Outcome Measures

Primary Outcomes (1)

  • Buprenorphine Plasma Cmax

    96 hours

Study Arms (1)

Study Arm

EXPERIMENTAL

Subjects will be studied on four occasions. Sessions and drugs are: 1. Intravenous buprenorphine 2. Sublingual buprenorphine 3. Cyclosporine plus intravenous buprenorphine 4. Cyclosporine plus sublingual buprenorphine

Drug: buprenorphine

Interventions

buprenorphineDRUG

Session 1 Intravenous buprenorphine: 0.2 mg over 1 hr Session 2 Sublingual buprenorphine: 2 mg Session 3 Intravenous buprenorphine 0.2 mg over 1 hr beginning 1 hr after starting cyclosporine Session 4 Sublingual buprenorphine: 2 mg after cyclosporine.

Study Arm

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • yr old
  • Good general health with no remarkable medical conditions
  • BMI \< 33
  • Provide informed consent

You may not qualify if:

  • Known history of liver or kidney disease
  • Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affecting CYP3A
  • Females who are pregnant or nursing
  • Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63012, United States

Location

MeSH Terms

Interventions

Buprenorphine

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Evan Kharasch MD PhD
Organization
Washington University
kharasch@wustl.edu
3143628796

Study Officials

  • Evan Kharasch, MD, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

July 24, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 22, 2020

Results First Posted

January 22, 2020

Record last verified: 2020-01

Locations

US(1)