A study to evaluate the relative bioavailability and effect of food on MK-3682B Fixed-Dose Combination Tablet (MK-3682/MK-8408/MK-5172)

Completed

Conditions: Hepatitis C
10047438

Registration Number: NL-OMON41831

Lead Sponsor: QPS Netherlands B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 22

Inclusion Criteria

1. Willing to give written informed consent, including for Future Biomedical Research.
2. Male or female 18 to 45 years of age (inclusive) at the pretrial (screening) visit.
3. Standard liver function tests including ALT, AST, alkaline phosphatase and total bilirubin do not exceed the upper limit of normal for the local laboratory at screening and on Day -1 of Period 1. If total bilirubin is elevated, direct bilirubin will be measured and the subject may be eligible for inclusion if direct bilirubin is within normal limits.

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<br /><br>(IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the<br /><br>fixeddose combination relative to the individual components when<br /><br>co-administered will be estimated.</p><br>

Secondary Outcome Measures

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