A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)

NCT ID: NCT01593735

Last Updated: 2015-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-02-28

Brief Summary

This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts. Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or may be staggered.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Panel A: GT1, low dose

Participants with genotype 1 (GT1) Hepatitis C Virus (HCV) will receive low dose MK-2748 daily for 7 days.

Group Type: EXPERIMENTAL

MK-2748

Intervention Type: DRUG

MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

Placebo

Intervention Type: DRUG

Placebo tablets, orally, once daily for 7 days

Panel B: GT1, lower dose

Participants with GT1 HCV will receive lower dose MK-2748 daily for 7 days.

Group Type: EXPERIMENTAL

MK-2748

Intervention Type: DRUG

MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

Placebo

Intervention Type: DRUG

Placebo tablets, orally, once daily for 7 days

Panel C: GT1, dose based on Panels A+B

Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose) and B (lower dose).

Group Type: EXPERIMENTAL

MK-2748

Intervention Type: DRUG

MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

Placebo

Intervention Type: DRUG

Placebo tablets, orally, once daily for 7 days

Panel G: GT1, dose based on Panels A+B+C

Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), and C.

Group Type: EXPERIMENTAL

MK-2748

Intervention Type: DRUG

MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

Placebo

Intervention Type: DRUG

Placebo tablets, orally, once daily for 7 days

Panel H: GT1, dose based on Panels A+B+C+G

Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), C, and G.

Group Type: EXPERIMENTAL

MK-2748

Intervention Type: DRUG

MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

Placebo

Intervention Type: DRUG

Placebo tablets, orally, once daily for 7 days

Panel D: GT3, low dose (Omitted)

Participants with genotype 3 (GT3) HCV were to receive low dose MK-2748 daily for 7 days. Panel D was omitted from the study design and participants were not enrolled in this panel.

Group Type: EXPERIMENTAL

MK-2748

Intervention Type: DRUG

MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

Placebo

Intervention Type: DRUG

Placebo tablets, orally, once daily for 7 days

Panel E: GT3, high dose

Participants with genotype 3 (GT3) HCV will receive high dose MK-2748 daily for 7 days.

Group Type: EXPERIMENTAL

MK-2748

Intervention Type: DRUG

MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

Placebo

Intervention Type: DRUG

Placebo tablets, orally, once daily for 7 days

Panel F: GT3, dose based on Panel E

Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panel E (high dose).

Group Type: EXPERIMENTAL

MK-2748

Intervention Type: DRUG

MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

Placebo

Intervention Type: DRUG

Placebo tablets, orally, once daily for 7 days

Panel I: GT3, dose based on Panels E+F

Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose) and F.

Group Type: EXPERIMENTAL

MK-2748

Intervention Type: DRUG

MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

Placebo

Intervention Type: DRUG

Placebo tablets, orally, once daily for 7 days

Panel J: GT3, dose based on Panels E+F+I

Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose), F, and I.

Group Type: EXPERIMENTAL

MK-2748

Intervention Type: DRUG

MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

Placebo

Intervention Type: DRUG

Placebo tablets, orally, once daily for 7 days

Interventions

MK-2748

MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment

Intervention Type: DRUG

Placebo

Placebo tablets, orally, once daily for 7 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of chronic HCV infection (GT1 or GT3) for at least 6 months and detectable HCV-RNA in peripheral blood
• Body mass index (BMI) of 18 to 37 kg/m^2
• No clinically significant abnormality on electrocardiogram (ECG)
• Stable health
• Willing to use appropriate contraception throughout the study and for 90 days after last dose of study drug

Exclusion Criteria

• Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
• History of stroke, chronic seizures, or major neurological disorder
• History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
• History of neoplastic disease (exceptions of adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, or other malignancies which have been successfully treated ≥10 years prior and unlikely to recur
• Positive Hepatitis B surface antigen
• Documented human immunodeficiency virus (HIV) infection
• Consumption of excessive amounts of alcohol, defined as greater than 2 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces],wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
• Consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) or coffee, tea, cola, or other caffeinated beverages per day
• Major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to study enrollment
• History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
• Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months prior to enrollment
• 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, autoimmune hepatitis
• Previous treatment with other HCV NS3/4A protease inhibitors
• Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to study enrollment
• Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3)
• Participation in another investigational study within 4 weeks prior to enrollment

• 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

Other Identifiers

2011-006296-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2748-002

Identifier Type: -

Identifier Source: org_study_id