Drug Interaction & Methadone & Buprenorphine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02045693
First received: January 21, 2014
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Methadone
Drug: DCV 3DAA FDC
Drug: BMS-791325
Drug: Buprenorphine
Drug: Naloxone
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Maximum observed concentration (Cmax) of R-Methadone for Part 1 [ Time Frame: 24 timepoints up to Day 13 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve in one dosing interval (AUC(TAU)) of R-Methadone for Part 1 [ Time Frame: 24 timepoints up to Day 13 ] [ Designated as safety issue: No ]
  • Cmax of Buprenorphine and Norbuprenorphine for Part 2 [ Time Frame: 24 timepoints up to Day 13 ] [ Designated as safety issue: No ]
  • AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2 [ Time Frame: 24 timepoints up to Day 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax of S-Methadone and Total Methadone for Part 1 [ Time Frame: 24 timepoints up to 13 days ] [ Designated as safety issue: No ]
  • AUC(TAU) of S-Methadone and Total Methadone for Part 1 [ Time Frame: 24 timepoints up to 13 days ] [ Designated as safety issue: No ]
  • Concentration at 24 hours (C24) of S-Methadone, Total Methadone and R-Methadone for Part 1 [ Time Frame: 24 timepoints up to 13 days ] [ Designated as safety issue: No ]
  • Time of maximum observed concentration (Tmax) of S-Methadone, Total Methadone and R-Methadone for Part 1 [ Time Frame: 24 timepoints up to 13 days ] [ Designated as safety issue: No ]
  • C24 of Buprenorphine and Norbuprenorphine for Part 2 [ Time Frame: 24 timepoints up to 13 days ] [ Designated as safety issue: No ]
  • Tmax of Buprenorphine and Norbuprenorphine for Part 2 [ Time Frame: 24 timepoints up to 13 days ] [ Designated as safety issue: No ]
  • Ratio of metabolite AUC(TAU) to parent AUC(TAU) (MR_AUC(TAU)) of Norbuprenorphine to Buprenorphine [ Time Frame: 24 timepoints up to 13 days ] [ Designated as safety issue: No ]
  • Cmax of of Daclatasvir (DCV) , Asunaprevir (ASV) , BMS-791325, and BMS-794712 [ Time Frame: 10 timepoints on Day 12 ] [ Designated as safety issue: No ]
  • AUC(TAU) of DCV, ASV, BMS-791325, and BMS-794712 [ Time Frame: 10 timepoints on Day 12 ] [ Designated as safety issue: No ]
  • Concentration at 12 hours (C12) of DCV, ASV, BMS-791325, and BMS-794712 [ Time Frame: 10 timepoints on Day 12 ] [ Designated as safety issue: No ]
  • Tmax of DCV, ASV, BMS-791325, and BMS-794712 [ Time Frame: 10 timepoints on Day 12 ] [ Designated as safety issue: No ]
  • MR_AUC(TAU) for BMS-794712 to BMS-791325 [ Time Frame: 10 timepoints on Day 12 ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation [ Time Frame: Up to day 13 ] [ Designated as safety issue: Yes ]
  • Results of vital signs, Electrocardiograms (ECGs), Physical Examinations (PEs) and clinical labs [ Time Frame: Up to day 13 ] [ Designated as safety issue: Yes ]
  • Scores of Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Objective Opiate Withdrawal Scale (OOWS), and Opiate Overdose Assessment (OOA) [ Time Frame: Up to day 13 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: February 2014
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Methadone + DCV 3DAA FDC + BMS-791325

Methadone 40-120 mg tablet or solution orally once on Day 1

Methadone 40-120 mg tablet or solution orally once daily + DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3 direct-acting antiviral (3DAA) fixed dose combination tablet) orally twice daily + BMS-791325 75 mg tablet orally twice daily on Days 2 through 12

Drug: Methadone Drug: DCV 3DAA FDC Drug: BMS-791325
Active Comparator: Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325

Buprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once on Day 1

Buprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once + DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3DAA fixed dose combination tablet) orally twice daily + BMS-791325 75 mg tablet orally twice daily on Days 2 through 12

Drug: DCV 3DAA FDC Drug: BMS-791325 Drug: Buprenorphine Drug: Naloxone

Detailed Description:

IND number: 101,943

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02045693

Locations
United States, California
Anaheim Clinical Trials Llc
Anaheim, California, United States, 92801
United States, Pennsylvania
Cri Lifetree
Philadelphia, Pennsylvania, United States, 19139
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02045693     History of Changes
Other Study ID Numbers: AI443-108
Study First Received: January 21, 2014
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Buprenorphine
Methadone
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 21, 2014