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Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)

NCT01329913 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-02-05

No results posted yet for this study

Summary

This is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in HCV-infected participants. Part I of the study will be for Genotype (GT) 1 HCV-infected participants who will be randomized to receive either MK-6325 or placebo. If the drug is shown to be safe and efficacious in Part I, Part II will enroll GT 3 HCV-infected participants who will be randomized to receive either MK-6325 or placebo.

Conditions

  • Hepatitis C

Interventions

DRUG

MK-6325

Two 100 mg capsules, orally, once per day for 7 days

DRUG

Placebo to MK-6325

Two 100 mg capsules, orally, once per day for 7 days

DRUG

MK-6325

Four 100 mg capsules, orally, once per day for 7 days

DRUG

Placebo to MK-6325

Four 100 mg capsules, orally, once per day for 7 days

DRUG

MK-6325

Eight 100 mg capsules, orally, once per day for 7 days

DRUG

Placebo to MK-6325

Eight 100 mg capsules, orally, once per day for 7 days

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-04-30
Completion
2012-04-30

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01329913 on ClinicalTrials.gov