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Completed

NCT Number: NCT02045693

Drug Interaction & Methadone & Buprenorphine

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials Llc, Anaheim, California, United States

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About this study

IND number: 101,943

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methadone

Drug

DCV 3DAA FDC

Drug

BMS-791325

Drug

buprenorphine

Drug

naloxone

Drug

Primary outcomes

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

    Time frame: 24 timepoints up to Day 13

  2. 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

  3. Cmax of Buprenorphine and Norbuprenorphine for Part 2

    Time frame: 24 timepoints up to Day 13

  4. AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2

    Time frame: 24 timepoints up to Day 13

Secondary outcomes

  1. Cmax of S-Methadone and Total Methadone for Part 1

    Time frame: 24 timepoints up to 13 days

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

    Time frame: 24 timepoints up to 13 days

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

    Time frame: 24 timepoints up to 13 days

  4. 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

  5. C24 of Buprenorphine and Norbuprenorphine for Part 2

    Time frame: 24 timepoints up to 13 days

  6. Tmax of Buprenorphine and Norbuprenorphine for Part 2

    Time frame: 24 timepoints up to 13 days

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

    Time frame: 24 timepoints up to 13 days

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

    Time frame: 10 timepoints on Day 12

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

    Time frame: 10 timepoints on Day 12

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

    Time frame: 10 timepoints on Day 12

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

    Time frame: 10 timepoints on Day 12

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

    Time frame: 10 timepoints on Day 12

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

    Time frame: Up to day 13

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

    Time frame: Up to day 13

  15. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 27, 2014
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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