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Study of Drug Combination on Pharmacokinetics in Healthy Volunteers

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02175602
Collaborator
(none)
41
Enrollment
2
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of Selective Serotonin Reuptake Inhibitors in Healthy Subjects
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 2

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

Drug: Sertraline
50 milligrams administered each morning
Other Names:
  • Zoloft

    • Drug: DCV 3DAA FDC
    Fixed dose combination (daclatasvir [DCV] 30 milligrams, asunaprevir [ASV] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily

    Drug: BMS-791325
    75 milligrams single-agent film coated oral tablet administered twice daily
    Experimental: Cohort 1

    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

    Drug: Escitalopram
    10 milligrams administered each morning
    Other Names:
  • Lexapro

    • Drug: DCV 3DAA FDC
    Fixed dose combination (daclatasvir [DCV] 30 milligrams, asunaprevir [ASV] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily

    Drug: BMS-791325
    75 milligrams single-agent film coated oral tablet administered twice daily

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. 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 Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Signed Informed Consent Form
    1. 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.
    1. Target Population
    1. 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.

    1. Age and Reproductive Status

    2. Males and females, ages 25 to 55 years, inclusive.

    3. 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.

    4. 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Principal Investigator: Ikenna Ogbaa, MD, PPD

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02175602
    Other Study ID Numbers:
    • AI443-116
    First Posted:
    Jun 26, 2014
    Last Update Posted:
    Feb 10, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Hepatitis C
    Citalopram
    Sertraline

    Study Results

    No Results Posted as of Feb 10, 2015