Safety, Pharmacokinetics, and Pharmacodynamics of MK-8876 in Participants With Hepatitis C Infection (MK-8876-003)

NCT ID: NCT01930058

Last Updated: 2018-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-02
• Study Completion Date: 2014-05-05

Brief Summary

This adaptive design study will evaluate the safety, pharmacokinetics, and effect on hepatitis C virus (HCV) RNA levels of multiple doses of MK-8876 in participants with HCV infection. The study will consist of 4 parts evaluating participants infected with specific hepatitis C virus genotypes and up to 10 panels allowing for additional participants to enroll in each panel as specified in the study analysis. The hypothesis evaluated in the study is that a ≥2.5 log IU/mL reduction in HCV RNA from Baseline will accompany multiple dose administration of MK-8876 in participants with HCV infection.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Panel A: HCV GT3 MK-8876 150 mg

Participants infected with HCV GT3 received 150 mg MK-8876 once daily (q.d.) by mouth for 7 days.

Group Type: EXPERIMENTAL

MK-8876

Intervention Type: DRUG

MK-8876 10 mg or 100 mg tablets taken q.d. by mouth.

Panel B: HCV GT3 MK-8876 800 mg

Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.

Group Type: EXPERIMENTAL

MK-8876

Intervention Type: DRUG

MK-8876 10 mg or 100 mg tablets taken q.d. by mouth.

Panel E: HCV GT1a MK-8876 800 mg

Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.

Group Type: EXPERIMENTAL

MK-8876

Intervention Type: DRUG

MK-8876 10 mg or 100 mg tablets taken q.d. by mouth.

Interventions

MK-8876

MK-8876 10 mg or 100 mg tablets taken q.d. by mouth.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• is male, or female of non-childbearing potential (non-childbearing potential is defined as postmenopausal without menses for ≥1 year or after medically documented hysterectomy, oophorectomy, or tubal ligation)
• agrees to use a medically acceptable method of contraception through 90 days after the last dose of study drug if participant has a female partner of childbearing potential must (males should use a condom and their partner of childbearing potential must use hormonal contraception, intrauterine device, diaphragm, cervical cap, or female condom)
• has a body mass index (BMI) between 18 and 37 kg/m^2
• has a clinical diagnosis of chronic HCV infection defined by positive serology for HCV for ≥6 months
• agrees to follow the smoking and other trial restrictions

Exclusion Criteria

• is mentally or legally institutionalized or incapacitated, has significant emotional problems at study start or has clinically significant psychiatric disorder of the last 5 years
• has a history of clinically significant endocrine, gastrointestinal (except HCV infection), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
• has a history of stroke, chronic seizures, or major neurological disorder
• has a history of cancer (except adequately treated non-melanomatous skin carcinoma, carcinoma in situ of the cervix, or other malignancies which have been successfully treated for ≥10 years
• has a history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to drugs or food
• has a history of clinically significant hepatic disease, Gilbert's disease, biliary tract disease, or human immunodeficiency virus
• has had major surgery or donated or lost >1 unit of blood within 4 weeks before the study
• has participated in another investigational trial within 4 weeks before the study
• Is unable to refrain from or anticipates the use of any medication from 2 weeks before the study and throughout the study
• consumes >2 glasses of alcoholic beverages per day
• consumes >6 servings (1 serving is ~120 mg caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day
• is a regular user of any illicit drugs or history of drug abuse within 12 months of the study
• has evidence or history of chronic hepatitis not caused by HCV (except acute non-HCV-related hepatitis that resolved >6 months before the study)
• has previously received treatment with another HCV non-nucleoside inhibitor (previous use of other HCV investigational therapies or marketed compounds is permitted if treatment ended ≥3 months before the study)
• has clinical or laboratory evidence of advanced or decompensated liver disease

• 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

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2013-002566-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8876-003

Identifier Type: -

Identifier Source: org_study_id