Study of Drug Combination on Pharmacokinetics in Healthy Volunteers

Phase 1

Completed

• Conditions: Hepatitis C Infection
• Interventions: Drug: Sertraline; Drug: Escitalopram; Drug: DCV 3DAA FDC; Drug: BMS-791325

• Registration Number: NCT02175602
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325 on the pharmacokinetics of selective serotonin reuptake inhibitors.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-26
• Primary Completion: 2014-08
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Signed Informed Consent Form

   a) Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.

2. Target Population

   a) Healthy subjects as determined by no clinically significant deviation from normal in medical history, psychiatric history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results.

3. Age and Reproductive Status

   1. Males and females, ages 25 to 55 years, inclusive.
   2. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
   3. Women must not be breastfeeding.

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Exclusion Criteria

1. Any significant acute or chronic medical illness.
2. Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug (appendectomies with no complications are allowed at the investigator's discretion).
3. Any major surgery within 4 weeks of study drug administration.
4. Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration).
5. Any other sound medical, psychiatric, and/or social reason as determined by the investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 2	DCV 3DAA FDC	Sertraline (50 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Sertraline (50 milligrams each morning) days 23-29
Cohort 1	DCV 3DAA FDC	Escitalopram (10 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Escitalopram (10 milligrams each morning) days 23-29
Cohort 2	BMS-791325	Sertraline (50 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Sertraline (50 milligrams each morning) days 23-29
Cohort 1	BMS-791325	Escitalopram (10 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Escitalopram (10 milligrams each morning) days 23-29
Cohort 2	Sertraline	Sertraline (50 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Sertraline (50 milligrams each morning) days 23-29
Cohort 1	Escitalopram	Escitalopram (10 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Escitalopram (10 milligrams each morning) days 23-29

Primary Outcome Measures

Name	Time	Method
Serial blood samples for determination of plasma concentrations of DCV (daclatasvir), ASV (asunaprevir), BMS-791325, and the metabolite BMS-794712	Before dosing (0 hour) through 12 hours after SSRI administration on day 22 and day 29
Serial blood samples for plasma SSRI (selective serotonin reuptake inhibitor) of escitalopram or sertraline	Before dosing (0 hour) through 24 hours after SSRI administration on day 7 and day 29

Secondary Outcome Measures

Name	Time	Method
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.	Two to three months