A Multiple Dose Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Participants (MK-5172-010)

• Status: Completed
• Trial end date: 2014-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study was to compare hepatic pharmacokinetics (PK) derived from liver tissue to plasma PK after administration of grazoprevir (MK-5172) to participants with chronic hepatitis C virus (HCV) infection. Participants will be randomized to one of four different liver ultrasound-guided Fine Needle Aspirate (FNA) schedules (at 4-, 8-, 24-, or 72-hours after the Day 7 dose).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Grazoprevir

Criteria

Inclusion criteria:

• has a Body Mass Index (BMI) ≥18.5 kg/m² and ≤36.0 kg/m²

• has chronic compensated, genotype 1 HCV infection

• has no cirrhosis of the liver as confirmed by FibroSure®/Fibro Test® and/or local country procedure (e.g. transient elastography/Fibroscan)

• does not require anticoagulants, nonsteroidal anti-inflammatory agents, and aspirin for at least fourteen (14) days preceding the initial liver biopsy and continuing throughout the entire study

• if is a female participant of reproductive potential, is willing to use 2 medically acceptable forms of contraception for 2 weeks prior to start of treatment through 2 weeks after last study treatment

• if is a male participant with a partner(s) of reproductive potential, is willing to use 2 medically acceptable forms of contraception from first dose to 90 days after last dose

Exclusion criteria:

• has a history of stroke, chronic seizures, or major neurological disorder

• has received previous treatment with a direct-acting antiviral (DAA)

• has evidence of high grade bridging fibrosis from prior liver biopsy within 3 years of study entry

• has evidence or history of chronic hepatitis not caused by HCV infection including but not limited to non-HCV viral hepatitis, nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, or autoimmune hepatitis

• has clinical or laboratory evidence of cirrhosis or other advanced liver disease

• has decompensated liver disease as indicated by a history of ascites, hepatic encephalopathy, or bleeding esophageal varices

• has been diagnosed with, or suspected of having, hepatocellular carcinoma (HCC)

• has clinically significant abnormality on an electrocardiogram (ECG)

• is co-infected with human immunodeficiency virus (HIV)

• is positive for Hepatitis B surface antigen (HBsAg) or other evidence of active Hepatitis B infection

• has a history of gastric bypass surgery, bowel resection or other disorder that may interfere with absorption

• has a history of clinically significant uncontrolled endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases

• has clinically significant neoplastic disease

• uses alcohol to excess, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [354 mL], wine [118 mL], or distilled spirits [29.5 mL]) per day

• is a current regular user (including use of any illicit drugs) or history of drug (including alcohol) abuse within the last 3 months

• has undergone surgery, donation of 1 unit of blood (approximately 500 mL) or participation in another investigational study within a period of 4 weeks prior to the screening visit

• has a history of multiple and/or severe allergies, or anaphylactic reaction or intolerability to prescription or nonprescription drugs or food

• is pregnant or lactating

• is expecting to donate eggs or sperm