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

NCT02269059 | Completed Phase 1

• 2 other identifiers: 7680-0032014-003674-16
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (3)

• 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

• Number of participants experiencing an adverse event (AE)

  Up to 21 days

• Number of participants discontinuing from study therapy due to AEs

  Up to 7 days

Study Arms (2)

GT1 Participants

EXPERIMENTAL

Participants take MK-7680 capsules by mouth once daily (QD) for 7 days. The starting dose will be 200 mg and the dose will be adjusted in successive panels of participants based on analysis of results of the previous panel.

Drug: MK-7680

GT3 Participants

EXPERIMENTAL

Participants take MK-7680 capsules by mouth QD for 7 days. The starting dose will be 200 mg and the dose will be adjusted in successive panels of participants based on analysis of results of the previous panel.

Drug: MK-7680

Interventions

MK-7680 DRUG

MK-7680 10 mg and 100 mg capsules

GT1 Participants; GT3 Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 20, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 27, 2015

Record last verified: 2015-07