Drug Interaction & Methadone & Buprenorphine

Condition(s) targeted: Hepatitis C

Intervention: Methadone (Drug); DCV 3DAA FDC (Drug); BMS-791325 (Drug); Buprenorphine (Drug); Naloxone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in subjects with the stable dose of Methadone and on the PK of Buprenorphine in subjects with the stable dose of Buprenorphine.

Official title: A Phase1, Open-Label, Drug-Drug Interaction Study Between Methadone and Daclatasvir/Asunaprevir/BMS-791325 3 DAA FDC + 75mg BMS-791325 and Between Buprenorphine/Naloxone and Daclatasvir/Asunaprevir/BMS-791325 3 DAA FDC +75mg BMS-791325

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Maximum observed concentration (Cmax) of R-Methadone for Part 1

Area under the concentration-time curve in one dosing interval (AUC(TAU)) of R-Methadone for Part 1

Cmax of Buprenorphine and Norbuprenorphine for Part 2

AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2

Secondary outcome:

Cmax of S-Methadone and Total Methadone for Part 1

AUC(TAU) of S-Methadone and Total Methadone for Part 1

Concentration at 24 hours (C24) of S-Methadone, Total Methadone and R-Methadone for Part 1

Time of maximum observed concentration (Tmax) of S-Methadone, Total Methadone and R-Methadone for Part 1

C24 of Buprenorphine and Norbuprenorphine for Part 2

Tmax of Buprenorphine and Norbuprenorphine for Part 2

Ratio of metabolite AUC(TAU) to parent AUC(TAU) (MR_AUC(TAU)) of Norbuprenorphine to Buprenorphine

Cmax of of Daclatasvir (DCV) , Asunaprevir (ASV) , BMS-791325, and BMS-794712

AUC(TAU) of DCV, ASV, BMS-791325, and BMS-794712

Concentration at 12 hours (C12) of DCV, ASV, BMS-791325, and BMS-794712

Tmax of DCV, ASV, BMS-791325, and BMS-794712

MR_AUC(TAU) for BMS-794712 to BMS-791325

Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation

Results of vital signs, Electrocardiograms (ECGs), Physical Examinations (PEs) and clinical labs

Scores of Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Objective Opiate Withdrawal Scale (OOWS), and Opiate Overdose Assessment (OOA)

Detailed description: IND number: 101,943 Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

For more information regarding BMS clinical trial participation, please visit www. BMSStudyConnect. com Inclusion Criteria:

- Subject must be on stable Methadone or Buprenorphine regimens for at least 28 days

prior to screening Exclusion Criteria:

- Subjects must be healthy except for history of Methadone or Buprenorphine treatment

regimens

- Prior exposure to DCV, ASV or BMS-791325 within 3 months of screening or any other

investigational drug or placebo within 4 weeks of study drug administration

Anaheim Clinical Trials Llc, Anaheim, California 92801, United States

Cri Lifetree, Philadelphia, Pennsylvania 19139, United States

Lifetree Clinical Research, Salt Lake City, Utah 84106, United States

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Starting date: February 2014
Last updated: June 16, 2014