Clinical trial NCT02045693: Drug Interaction & Methadone & 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-01-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: IND number: 101,943

Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Eligibility 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

Primary outcomes:
measure: Maximum observed concentration (Cmax) of R-Methadone for Part 1
timeFrame: 24 timepoints up to Day 13
measure: Area under the concentration-time curve in one dosing interval (AUC(TAU)) of R-Methadone for Part 1
timeFrame: 24 timepoints up to Day 13
measure: Cmax of Buprenorphine and Norbuprenorphine for Part 2
timeFrame: 24 timepoints up to Day 13
measure: AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2
timeFrame: 24 timepoints up to Day 13
Secondary outcomes:
measure: Cmax of S-Methadone and Total Methadone for Part 1
timeFrame: 24 timepoints up to 13 days
measure: AUC(TAU) of S-Methadone and Total Methadone for Part 1
timeFrame: 24 timepoints up to 13 days
measure: Concentration at 24 hours (C24) of S-Methadone, Total Methadone and R-Methadone for Part 1
timeFrame: 24 timepoints up to 13 days
measure: Time of maximum observed concentration (Tmax) of S-Methadone, Total Methadone and R-Methadone for Part 1
timeFrame: 24 timepoints up to 13 days
measure: C24 of Buprenorphine and Norbuprenorphine for Part 2
timeFrame: 24 timepoints up to 13 days
measure: Tmax of Buprenorphine and Norbuprenorphine for Part 2
timeFrame: 24 timepoints up to 13 days
measure: Ratio of metabolite AUC(TAU) to parent AUC(TAU) (MR_AUC(TAU)) of Norbuprenorphine to Buprenorphine
timeFrame: 24 timepoints up to 13 days
measure: Cmax of of Daclatasvir (DCV) , Asunaprevir (ASV) , BMS-791325, and BMS-794712
timeFrame: 10 timepoints on Day 12
measure: AUC(TAU) of DCV, ASV, BMS-791325, and BMS-794712
timeFrame: 10 timepoints on Day 12
measure: Concentration at 12 hours (C12) of DCV, ASV, BMS-791325, and BMS-794712
timeFrame: 10 timepoints on Day 12
measure: Tmax of DCV, ASV, BMS-791325, and BMS-794712
timeFrame: 10 timepoints on Day 12
measure: MR_AUC(TAU) for BMS-794712 to BMS-791325
timeFrame: 10 timepoints on Day 12
measure: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation
timeFrame: Up to day 13
measure: Results of vital signs, Electrocardiograms (ECGs), Physical Examinations (PEs) and clinical labs
timeFrame: Up to day 13
measure: Scores of Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Objective Opiate Withdrawal Scale (OOWS), and Opiate Overdose Assessment (OOA)
timeFrame: Up to day 13
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials Llc
state: California
city: Philadelphia
country: United States
facility: Cri Lifetree
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: