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