A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Hepatitis C, Chronic

Treatments: Drug: MK-8325; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01554189

2011-006263-22 (EudraCT Number)

8325-002

Details and patient eligibility

About

This study is being done to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-8325 in male hepatitis C virus (HCV)-infected participants. There will be 3 parts to this study. Part I will enroll only genotype 1 (GT1) HCV patients, Part II will enroll only genotype 3 (GT3) HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or may be staggered as needed by the clinical sites.

Enrollment: 37 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) of 18 to ≤37 kg/m^2
• Diagnosis of chronic HCV infection
• Must be infected with HCV GT1a, GT1b, or GT3

Exclusion criteria

• Co-infection with GT1 and GT3 HCV
• History of stroke, chronic seizures, or major neurological disorder
• History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
• History of neoplastic disease
• Positive Hepatitis B surface antigen
• History of human immunodeficiency virus (HIV) infection or positive HIV serology
• Major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior
• History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
• Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months
• 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, autoimmune hepatitis
• Previous treatments(s) with nonstructural 5A (NS5A) protein inhibitors
• Treatment with protease inhibitor(s) <30 days prior to study enrollment
• Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to the first dose of MK-8325 in the study
• 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: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 11 patient groups, including a placebo group

Panel A (GT1 10 mg)

Experimental group

Treatment:

Drug: MK-8325

Panel B (GT1 50 mg)

Experimental group

Treatment:

Drug: MK-8325

Panel C (GT1 100 mg)

Experimental group

Treatment:

Drug: MK-8325

Panel D (GT1 200 mg)

Experimental group

Treatment:

Drug: MK-8325

Panel E (GT3 10 mg)

Experimental group

Treatment:

Drug: MK-8325

Panel F (GT3 50 mg)

Experimental group

Treatment:

Drug: MK-8325

Panel G (GT3 100 mg)

Experimental group

Treatment:

Drug: MK-8325

Panel H (GT3 200 mg)

Experimental group

Treatment:

Drug: MK-8325

Panel I (GT1a 10 mg)

Experimental group

Treatment:

Drug: MK-8325

Panel J (GT1a 50 mg)

Experimental group

Treatment:

Drug: MK-8325

Placebo Panel

Placebo Comparator group

Treatment:

Drug: Placebo