Hepatitis C Infection
Conditions
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.
Interventions
DRUGEscitalopram
10 milligrams administered each morning
DRUGSertraline
50 milligrams administered each morning
DRUGDCV 3DAA FDC
Fixed dose combination (daclatasvir \[DCV\] 30 milligrams, asunaprevir \[ASV\] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily
DRUGBMS-791325
75 milligrams single-agent film coated oral tablet administered twice daily
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. | Two to three months |
Outcome results
None listed