Back to resultsStudy of Drug Combination on Pharmacokinetics in Healthy Volunteers
Primary Purpose
Hepatitis C Infection
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Escitalopram
Sertraline
DCV 3DAA FDC
BMS-791325
Sponsored by
About this trial
This is an interventional basic science trial for Hepatitis C Infection
Eligibility Criteria
Inclusion Criteria:
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.
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.
Age and Reproductive Status
- Males and females, ages 25 to 55 years, inclusive.
- 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.
- Women must not be breastfeeding.
Exclusion Criteria:
- Any significant acute or chronic medical illness.
- 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).
- Any major surgery within 4 weeks of study drug administration.
- 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).
- Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 2
Cohort 1
Arm 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
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
Outcomes
Primary Outcome Measures
Serial blood samples for plasma SSRI (selective serotonin reuptake inhibitor) of escitalopram or sertraline
Serial blood samples for determination of plasma concentrations of DCV (daclatasvir), ASV (asunaprevir), BMS-791325, and the metabolite BMS-794712
Secondary Outcome Measures
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02175602
Brief Title
Study of Drug Combination on Pharmacokinetics in Healthy Volunteers
Official Title
Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of Selective Serotonin Reuptake Inhibitors in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Infection
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 2
Arm Type
Experimental
Arm 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
Arm Title
Cohort 1
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
10 milligrams administered each morning
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
50 milligrams administered each morning
Intervention Type
Drug
Intervention Name(s)
DCV 3DAA FDC
Intervention Description
Fixed dose combination (daclatasvir [DCV] 30 milligrams, asunaprevir [ASV] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily
Intervention Type
Drug
Intervention Name(s)
BMS-791325
Intervention Description
75 milligrams single-agent film coated oral tablet administered twice daily
Primary Outcome Measure Information:
Title
Serial blood samples for plasma SSRI (selective serotonin reuptake inhibitor) of escitalopram or sertraline
Time Frame
Before dosing (0 hour) through 24 hours after SSRI administration on day 7 and day 29
Title
Serial blood samples for determination of plasma concentrations of DCV (daclatasvir), ASV (asunaprevir), BMS-791325, and the metabolite BMS-794712
Time Frame
Before dosing (0 hour) through 12 hours after SSRI administration on day 22 and day 29
Secondary Outcome Measure Information:
Title
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
Time Frame
Two to three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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.
Age and Reproductive Status
Males and females, ages 25 to 55 years, inclusive.
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.
Women must not be breastfeeding.
Exclusion Criteria:
Any significant acute or chronic medical illness.
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).
Any major surgery within 4 weeks of study drug administration.
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).
Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ikenna Ogbaa, MD
Organizational Affiliation
PPD
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of Drug Combination on Pharmacokinetics in Healthy Volunteers
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