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

NCT ID: NCT01537900

Last Updated: 2018-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-01
• Study Completion Date: 2014-07-31

Brief 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).

Conditions

Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Grazoprevir 100 mg

Participants received GZR 100 mg once daily (q.d.) for 7 days. Liver FNA was performed on Day 7.

Group Type: EXPERIMENTAL

Grazoprevir

Intervention Type: DRUG

GZR 100 mg tablet by mouth q.d. for 7 days.

Interventions

Grazoprevir

GZR 100 mg tablet by mouth q.d. for 7 days.

Intervention Type: DRUG

Other Intervention Names

MK-5172

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2011-000435-83

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

5172-010

Identifier Type: -

Identifier Source: org_study_id