Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: MK-1075

Study type: Interventional

Funder types: Industry

Identifiers

NCT02392494

2015-000127-93 (EudraCT Number)

1075-002

MK-1075-002 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to determine the ability of MK-1075 to reduce HCV viral load, following administration of a single dose in HCV-infected participants.

Full description

Per protocol, panels may be omitted if the objectives of the study are met in preceding panels.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female of non-child bearing potential
• In good health other than HCV genotype (GT) 1 infection

Exclusion criteria

• Is mentally incapacitated or legally institutionalized
• 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 (including stroke and chronic seizures) abnormalities or diseases
• Has a history of cancer
• Is positive for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV)
• Has participated in another investigational trial within 4 weeks (or 5 half-lives) prior to Screening
• Consumes >2 alcoholic beverages a day or uses illegal drugs
• Has evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, or autoimmune hepatitis
• Has clinical or laboratory evidence of advanced or decompensated liver disease, evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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9 participants in 4 patient groups

MK-1075 100 mg (Panel A)

Experimental group

Description:

HCV-infected participants receive a single 100 mg dose of MK-1075.

Treatment:

Drug: MK-1075

MK-1075 200 mg (Panel B)

Experimental group

Description:

HCV-infected participants receive a single 200 mg dose of MK-1075.

Treatment:

Drug: MK-1075

MK-1075 400 mg (Panel C)

Experimental group

Description:

HCV-infected participants receive a single 400 mg dose of MK-1075.

Treatment:

Drug: MK-1075

MK-1075 800 mg (Panel D)

Experimental group

Description:

HCV-infected participants receive a single 800 mg dose of MK-1075.

Treatment:

Drug: MK-1075