A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004)
Hepatitis C Virus Infection
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
GT1: 200 mg MK-1075
GT1: 400 mg MK-1075
GT1: 800 mg MK-1075
GT3: 200 mg MK-1075
GT3: 400 mg MK-1075
GT3: 800 mg MK-1075
Fasted GT1 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
Fasted GT1 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
Fasted GT1 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
Fasted GT3 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
Fasted GT3 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
Fasted GT3 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days