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Drug Interaction & Methadone & Buprenorphine

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02045693
Collaborator
(none)
32
Enrollment
3
Locations
2
Arms
1.9
Duration (Months)
10.7
Patients Per Site
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

IND number: 101,943

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

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Maximum observed concentration (Cmax) of R-Methadone for Part 1 [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 [24 timepoints up to Day 13]

  3. Cmax of Buprenorphine and Norbuprenorphine for Part 2 [24 timepoints up to Day 13]

  4. AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2 [24 timepoints up to Day 13]

Secondary Outcome Measures

  1. Cmax of S-Methadone and Total Methadone for Part 1 [24 timepoints up to 13 days]

  2. AUC(TAU) of S-Methadone and Total Methadone for Part 1 [24 timepoints up to 13 days]

  3. Concentration at 24 hours (C24) of S-Methadone, Total Methadone and R-Methadone for Part 1 [24 timepoints up to 13 days]

  4. Time of maximum observed concentration (Tmax) of S-Methadone, Total Methadone and R-Methadone for Part 1 [24 timepoints up to 13 days]

  5. C24 of Buprenorphine and Norbuprenorphine for Part 2 [24 timepoints up to 13 days]

  6. Tmax of Buprenorphine and Norbuprenorphine for Part 2 [24 timepoints up to 13 days]

  7. Ratio of metabolite AUC(TAU) to parent AUC(TAU) (MR_AUC(TAU)) of Norbuprenorphine to Buprenorphine [24 timepoints up to 13 days]

  8. Cmax of of Daclatasvir (DCV) , Asunaprevir (ASV) , BMS-791325, and BMS-794712 [10 timepoints on Day 12]

  9. AUC(TAU) of DCV, ASV, BMS-791325, and BMS-794712 [10 timepoints on Day 12]

  10. Concentration at 12 hours (C12) of DCV, ASV, BMS-791325, and BMS-794712 [10 timepoints on Day 12]

  11. Tmax of DCV, ASV, BMS-791325, and BMS-794712 [10 timepoints on Day 12]

  12. MR_AUC(TAU) for BMS-794712 to BMS-791325 [10 timepoints on Day 12]

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

  14. Results of vital signs, Electrocardiograms (ECGs), Physical Examinations (PEs) and clinical labs [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) [Up to day 13]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Locations

Site City State Country Postal Code
1 Anaheim Clinical Trials Llc Anaheim California United States 92801
2 Cri Lifetree Philadelphia Pennsylvania United States 19139
3 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02045693
Other Study ID Numbers:
  • AI443-108
First Posted:
Jan 27, 2014
Last Update Posted:
Jun 17, 2014
Last Verified:
Jun 1, 2014
Additional relevant MeSH terms:
Hepatitis C
Buprenorphine
Methadone
Naloxone

Study Results

No Results Posted as of Jun 17, 2014