Healthy
Conditions
Keywords
buprenorphine, CYP3A
Brief summary
The determine the effect of cyclosporine on buprenorphine disposition
Detailed description
Subjects studied on four occasions: 1. Intravenous buprenorphine 2. Sublingual buprenorphine 3. Cyclosporine, then intravenous buprenorphine. Subjects then take oral cyclosporine twice daily, until 4. Sublingual buprenorphine; continue oral cyclosporine twice daily for 5 days
Interventions
DRUGbuprenorphine
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.
Sponsors
Washington University School of Medicine
Study design
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-50 yr old * Good general health with no remarkable medical conditions * BMI \< 33 * Provide informed consent
Exclusion criteria
* 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) * Direct physical access to and routine handling of addicting drugs in the regular course of duty (a routine exclusion from studies of drugs with addiction potential)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Buprenorphine Plasma Cmax | 96 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Arm 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 | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Intravenous Buprenorphine | Withdrawal by Subject | 12 |
Baseline characteristics
| Characteristic | Study Arm |
|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 16 / 18 | 17 / 18 | 17 / 18 | 18 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Buprenorphine Plasma Cmax
Time frame: 96 hours
Population: 0 Participants Analyzed. The PI has left the institution. Sincere efforts were made to contact the PI but were unsuccessful. No study data are available.