Drug Interaction & Methadone & Buprenorphine

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045693
• Other study ID #: AI443-108
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2014
• Last updated: June 16, 2014
• Start date: February 2014
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

IND number: 101,943

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• Methadone

• DCV 3DAA FDC

• BMS-791325

• Buprenorphine

• Naloxone

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials Llc	Anaheim	California
United States	Cri Lifetree	Philadelphia	Pennsylvania
United States	Lifetree Clinical Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax) of R-Methadone for Part 1		24 timepoints up to Day 13	No
Primary	Area under the concentration-time curve in one dosing interval (AUC(TAU)) of R-Methadone for Part 1		24 timepoints up to Day 13	No
Primary	Cmax of Buprenorphine and Norbuprenorphine for Part 2		24 timepoints up to Day 13	No
Primary	AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2		24 timepoints up to Day 13	No
Secondary	Cmax of S-Methadone and Total Methadone for Part 1		24 timepoints up to 13 days	No
Secondary	AUC(TAU) of S-Methadone and Total Methadone for Part 1		24 timepoints up to 13 days	No
Secondary	Concentration at 24 hours (C24) of S-Methadone, Total Methadone and R-Methadone for Part 1		24 timepoints up to 13 days	No
Secondary	Time of maximum observed concentration (Tmax) of S-Methadone, Total Methadone and R-Methadone for Part 1		24 timepoints up to 13 days	No
Secondary	C24 of Buprenorphine and Norbuprenorphine for Part 2		24 timepoints up to 13 days	No
Secondary	Tmax of Buprenorphine and Norbuprenorphine for Part 2		24 timepoints up to 13 days	No
Secondary	Ratio of metabolite AUC(TAU) to parent AUC(TAU) (MR_AUC(TAU)) of Norbuprenorphine to Buprenorphine		24 timepoints up to 13 days	No
Secondary	Cmax of of Daclatasvir (DCV) , Asunaprevir (ASV) , BMS-791325, and BMS-794712		10 timepoints on Day 12	No
Secondary	AUC(TAU) of DCV, ASV, BMS-791325, and BMS-794712		10 timepoints on Day 12	No
Secondary	Concentration at 12 hours (C12) of DCV, ASV, BMS-791325, and BMS-794712		10 timepoints on Day 12	No
Secondary	Tmax of DCV, ASV, BMS-791325, and BMS-794712		10 timepoints on Day 12	No
Secondary	MR_AUC(TAU) for BMS-794712 to BMS-791325		10 timepoints on Day 12	No
Secondary	Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation		Up to day 13	Yes
Secondary	Results of vital signs, Electrocardiograms (ECGs), Physical Examinations (PEs) and clinical labs		Up to day 13	Yes
Secondary	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	No

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