A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004)

NCT ID: NCT02461563

Last Updated: 2018-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-23
• Study Completion Date: 2015-12-23

Brief Summary

This study will evaluate safety, pharmacokinetics (PK), and the ability of MK-1075 to suppress viral load (VL) in HCV-infected participants during 7 days of once daily dose administration. The primary hypothesis is at a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, the mean maximum HCV RNA (log10 IU/mL) reduction is at least 3 log10 IU/mL as compared to baseline following multiple dose oral administration of MK-1075 in HCV genotype 1 (GT1) and genotype 3 (GT3) infected participants.

Conditions

Hepatitis C Virus Infection

Study Design

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

Study Groups

GT1: 200 mg MK-1075

Fasted GT1 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days

Group Type: EXPERIMENTAL

200 mg MK-1075

Intervention Type: DRUG

Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

GT1: 400 mg MK-1075

Fasted GT1 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days

Group Type: EXPERIMENTAL

400 mg MK-1075

Intervention Type: DRUG

Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

GT1: 800 mg MK-1075

Fasted GT1 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days

Group Type: EXPERIMENTAL

800 mg MK-1075

Intervention Type: DRUG

Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

GT3: 200 mg MK-1075

Fasted GT3 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days

Group Type: EXPERIMENTAL

200 mg MK-1075

Intervention Type: DRUG

Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

GT3: 400 mg MK-1075

Fasted GT3 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days

Group Type: EXPERIMENTAL

400 mg MK-1075

Intervention Type: DRUG

Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

GT3: 800 mg MK-1075

Fasted GT3 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days

Group Type: EXPERIMENTAL

800 mg MK-1075

Intervention Type: DRUG

Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

Interventions

200 mg MK-1075

Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

Intervention Type: DRUG

400 mg MK-1075

Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

Intervention Type: DRUG

800 mg MK-1075

Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female of non-childbearing potential
• Have a body mass index (BMI) >=18 to =< 37 kg/m^2
• Excepting HCV infection, be in good health
• Have a clinical diagnosis of chronic HCV infection, exclusively GT1 or exclusively GT3
• Agree to follow smoking restrictions

Exclusion Criteria

• Has a history of clinically significant, not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
• Have been treated with amiodarone within the prior year, or is currently on beta-blockers or verapamil
• Has a history of cancer (malignancy)
• Has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
• Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV)
• Has had major surgery, donated or lost approximately 500 mL blood within 4 weeks prior to screening visit
• Has participated in another drug trial within 4 weeks prior to screening visit
• Is taking a non-permitted medication to treat a co-morbid condition
• Consumes greater than 2 glasses of alcoholic beverages
• Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months
• Has evidence or history of chronic hepatitis not caused by HCV, including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, or autoimmune hepatitis
• Has been treated with other HCV inhibitors, such as sofosbuvir or VX-135
• Has evidence of advanced or decompensated liver disease, bridging fibrosis or higher grade fibrosis from a prior liver biopsy

• 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

2015-001687-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1075-004

Identifier Type: -

Identifier Source: org_study_id