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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Hepatitis C

Treatments

Drug: Grazoprevir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01537900

2011-000435-83 (EudraCT Number)

5172-010

Details and patient eligibility

About

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).

Enrollment

4 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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