A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone
Status: | Completed |
---|---|
Conditions: | HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 8/10/2017 |
Start Date: | January 12, 2016 |
End Date: | June 29, 2016 |
A Phase 1, Open-Label, Drug-Drug Interaction Study Between Methadone and BMS-663068; and Between Buprenorphine/Naloxone and BMS-663068
The study is being conducted to assess the effect of multiple doses of BMS-663068 on the
exposure of methadone in subjects on a stable dose of methadone, and the exposure of
buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and
norbuprenorphine.
exposure of methadone in subjects on a stable dose of methadone, and the exposure of
buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and
norbuprenorphine.
Inclusion Criteria:
1. Signed Informed Consent
2. Target population: Subjects on methadone maintenance therapy (for inclusion in Part 1)
or buprenorphine and norbuprenorphine maintenance therapy (for inclusion in Part 2),
who have been reliably participating in an oral methadone or buprenorphine and
norbuprenorphine program and who are on a stable dose for at least 30 days prior to
study screening
3. Male and Female Subjects with body mass index of 18 to 34 kg/m2, inclusive
4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
and must not be breastfeeding
5. Men and WOCBP must agree to follow instructions for contraception
Exclusion Criteria:
1. History of any chronic or acute illness, gastrointestinal disease, smoking and alcohol
abuse
2. Any Gastrointestinal (GI) surgery within 4 weeks of study drug administration that
could affect its absorption
3. Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, ECG or clinical laboratory determinations beyond
what is consistent with the target population.
4. History of allergy to any drugs, BMS-663068, HIV attachment inhibitors, or related
compounds
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