A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-8408 in Subjects with Hepatitis C Infectio

Completed

• Conditions: Hepatitis C; 10047438

• Registration Number: NL-OMON41065
• Lead Sponsor: Merck Sharp & Dohme (MSD)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

1. Male or Female (of non-child bearing potential) subjects with verified HCV infection with
GT1a, GT2b or GT3 between the ages of 18 and 65 years (inclusive)
2. have a Body Mass Index (BMI) >=18 to <=37 kg/m2
3. Be judged to be in good health, except for HCV infection

Exclusion Criteria

1. Subject is mentally or legally institutionalized / incapacitated, has significant emotional problems at the time of pretrial (screening) visit or expected during the conduct of the trial or has a history of clinically significant psychiatric disorder of the last 5 years.
2. Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological
(including stroke and chronic seizures) abnormalities or diseases.
3.Subject has a history of cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Viral load<br /><br>safety<br /><br>tolerability</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>plasma pharmacokinetic (PK) profile</p><br>