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OpenTrials
Completed

NCT Number: NCT02269059

Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)

This is a two-part dose-finding trial of MK-7680 in participants with Hepatitis C Virus (HCV) infection of genotype (GT)1 (Part I) and GT3 (Part 2). The primary hypothesis is that daily administration of a safe and well tolerated dose of MK-7680 will produce a decrease in HCV viral load.

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Key information

About this study

Parts 1 and 2 will each consist of 4 panels. In the first panel, a 200 mg dose of MK-7680 will be administered. In each of the following 3 panels, higher or lower doses of MK-7680 will be administered. Each panel will only begin once the safety and tolerability data from the preceding panel have been evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is in good health except for HCV infection
  • Is male or is a female of non-childbearing potential
  • Clinical diagnosis of HCV GT1 or GT3 with no evidence of mixed-GT or non-typeable infection

Exclusion criteria

  • Has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary, or major neurological abnormality or disease
  • Has a history of cancer
  • Has a history of significant multiple and/or severe allergies
  • Is positive for hepatitis B or human immunodeficiency virus
  • Has had major surgery, donated or lost 1 unit (500 mL) of blood within 4 weeks prior to screening
  • Consumes more than 2 alcoholic beverages per day or is currently a regular user of any illicit drug(s) or has a history of alcohol/drug abuse within 12 months prior to screening
  • Has chronic hepatitis not caused by HCV (e.g., nonalcoholic steatohepatitis [NASH])
  • Has clinical or laboratory evidence of advanced or decompensated liver disease, or evidence of bridging or higher grade fibrosis

Treatment and study plan

MK-7680

Drug

MK-7680 10 mg and 100 mg capsules

Primary outcomes

  1. Change from baseline in HCV viral load

    Time frame: Day 1: predose, 2, 4, 8, 12, and 24 hours postdose; Days 3, 4, 5, and 6: predose; and Day 7: predose, 4, 12, 24, and 48 hours postdose

  2. Number of participants experiencing an adverse event (AE)

    Time frame: Up to 21 days

  3. Number of participants discontinuing from study therapy due to AEs

    Time frame: Up to 7 days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-7680 in Patients With Hepatitis C Infection

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 20, 2014
Registry last updated
Jul 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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