Safety, Pharmacokinetics, and Pharmacodynamics of Ruzasvir (MK-8408) in Participants With Hepatitis C Infection (MK-8408-003)

NCT ID: NCT02076100

Last Updated: 2018-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-27
• Study Completion Date: 2015-11-15

Brief Summary

This is a 3-part study of Ruzasvir (MK-8408) for participants with hepatitis C infection. Successive participants will be enrolled as dose levels are evaluated to find the maximum safe and well tolerated dose of Ruzasvir. Part I will be for participants with hepatitis C virus (HCV) genotype 3 (GT3) and will run first: Part II will be for participants with HCV genotype 1a (GT1a), and Part III will be for participants with HCV genotype 2b (GT2b). Parts II and III may run concurrently. The primary study hypothesis is that a safe and tolerable dose of Ruzasvir that reduces viral load will be found to support further clinical investigation.

Conditions

Hepatitis C Infection

Study Design

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

Study Groups

Part I GT3 Participants

Participants receive Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated.

Group Type: EXPERIMENTAL

Ruzasvir

Intervention Type: DRUG

Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated.

Part II GT1a Participants

Participants receive Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated.

Group Type: EXPERIMENTAL

Ruzasvir

Intervention Type: DRUG

Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated.

Part III GT2b Participants

Participants receive Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated.

Group Type: EXPERIMENTAL

Ruzasvir

Intervention Type: DRUG

Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated.

Interventions

Ruzasvir

Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated.

Intervention Type: DRUG

Other Intervention Names

MK-8408

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) >=18 to<=37 kg/m^2
• In general good health, except for HCV infection
• Clinical diagnosis of chronic HCV infection exclusively GT3 (Panels A-D) or exclusively GT1a (Panels E-F), or exclusively GT2b (Panels G-H).
• Must agree to follow the smoking restrictions defined by the CRU
• Must agree to use an acceptable method of contraception during the study and for 90 days after the last dose of ruzasvir

Exclusion Criteria

• Clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases
• History of clinically significant hepatic disease, Gilbert's disease or biliary tract disease
• History of cancer (malignancy) with the exception of adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, or successfully-treated malignancies ≥10 years prior to screening
• History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
• Positive for hepatitis B or human immunodeficiency virus (HIV)
• Major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to screening
• Participated in another investigational trial within 4 weeks prior to the screening visit
• QTc interval >=470 msec (for males) or >= 480 msec (for females)
• Unable to refrain from or anticipates use of any medication (prescription and/or non-prescription) or herbal remedies beginning approximately 2 weeks prior to first study drug dose, throughout the trial until the post-trial visit
• Consumes >2 glasses of alcoholic beverages per day
• Regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 12 months
• Evidence or history of chronic hepatitis not caused by HCV
• Previous treatment with other HCV NS5A inhibitors such as MK-8742, daclatasvir, or MK-8325
• Treatment with other HCV therapies such as the HCV protease
• Evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score >=3)

• 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

Countries

Germany; Moldova; Netherlands; New Zealand

Other Identifiers

2013-005094-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-8408-003

Identifier Type: OTHER

Identifier Source: secondary_id

8408-003

Identifier Type: -

Identifier Source: org_study_id