Study of Drug Combination on Pharmacokinetics in Healthy Volunteers

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C Infection

Treatments: Drug: Escitalopram; Drug: DCV 3DAA FDC; Drug: BMS-791325; Drug: Sertraline

Study type: Interventional

Funder types: Industry

Identifiers

NCT02175602

AI443-116

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: Sertraline

Drug: DCV 3DAA FDC

Drug: BMS-791325

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: DCV 3DAA FDC

Drug: Escitalopram

Drug: BMS-791325