Study of Drug Combination on Pharmacokinetics in Healthy Volunteers

Hepatitis C Infection Clinical Trial

Official title:

Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of Selective Serotonin Reuptake Inhibitors in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175602
• Other study ID #: AI443-116
• Status: Completed
• Phase: Phase 1
• First received: June 24, 2014
• Last updated: February 9, 2015
• Start date: June 2014

Study information

• Verified date: February 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Infection

Intervention

Drug:
• Escitalopram
10 milligrams administered each morning
• Sertraline
50 milligrams administered each morning
• DCV 3DAA FDC
Fixed dose combination (daclatasvir [DCV] 30 milligrams, asunaprevir [ASV] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily
• BMS-791325
75 milligrams single-agent film coated oral tablet administered twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.		Two to three months	Yes