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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C Virus Infection

Treatments: Drug: 200 mg MK-1075; Drug: 800 mg MK-1075; Drug: 400 mg MK-1075

Study type: Interventional

Funder types: Industry

Identifiers

NCT02461563

2015-001687-18 (EudraCT Number)

1075-004

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 6 patient groups

GT1: 200 mg MK-1075

Experimental group

Description:

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

Treatment:

Drug: 200 mg MK-1075

GT1: 400 mg MK-1075

Experimental group

Description:

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

Treatment:

Drug: 400 mg MK-1075

GT1: 800 mg MK-1075

Experimental group

Description:

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

Treatment:

Drug: 800 mg MK-1075

GT3: 200 mg MK-1075

Experimental group

Description:

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

Treatment:

Drug: 200 mg MK-1075

GT3: 400 mg MK-1075

Experimental group

Description:

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

Treatment:

Drug: 400 mg MK-1075

GT3: 800 mg MK-1075

Experimental group

Description:

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

Treatment:

Drug: 800 mg MK-1075