A study to evaluate the relative bioavailability and effect of food on two 450mg MK-3682 Fixed-Dose Combination Formulations (MK-3682 /MK-5172 /MK-8408)

Completed

Conditions: Hepatitis C
10047438

Registration Number: NL-OMON41967

Lead Sponsor: Merck Sharp & Dohme (MSD)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

1. Be willing to give written informed consent, including for Future Biomedical Research.
2. Be male or female, 18 to 55 years of age (inclusive) at the pretrial (screening) visit.
3. Standard liver function tests including ALT, AST, alkaline phosphatase and bilirubin (total and direct) do not exceed the upper limit of normal for the local laboratory at Screening and Day -1 of Period 1.

Exclusion Criteria

1. A history of liver disease (exception: subjects with remote hepatitis A virus infection with full recovery can be included).
2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
3. A history of cancer (malignancy).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The pharmacokinetic (PK) parameters (AUC0-t, AUC0-, Cmax, C24, Tmax, and<br /><br>apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and<br /><br>IDX23267), MK-5172, and MK-8408 following administration of the fixed-dose<br /><br>combinations relative to the individual components when co-administered will be<br /><br>estimated.<br /><br><br /><br>The effects of a high fat meal on the pharmacokinetic (PK) parameters (AUC0-t,<br /><br>AUC0-, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating<br /><br>metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following<br /><br>administration of the fixed-dose combinations relative to the fasted state will<br /><br>be estimated.</p><br>

Secondary Outcome Measures