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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269059
• Other study ID #: 7680-003
• Secondary ID: 2014-003674-16
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2014
• Last updated: July 24, 2015
• Start date: December 2014
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• MK-7680
MK-7680 10 mg and 100 mg capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HCV viral load		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	No
Primary	Number of participants experiencing an adverse event (AE)		Up to 21 days	Yes
Primary	Number of participants discontinuing from study therapy due to AEs		Up to 7 days	Yes