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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02076100
• Date of registration: 27/02/2014
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Safety, Pharmacokinetics, and Pharmacodynamics of Ruzasvir (MK-8408) in Participants With Hepatitis C Infection (MK-8408-003)
• Scientific title: A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-8408 in Subjects With Hepatitis C Infection
• Date of first enrolment: March 27, 2014
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02076100
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Germany, Moldova, Republic of, Netherlands, New Zealand

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis C Infection

Intervention(s)

Drug: Ruzasvir

Primary Outcome(s)

Number of Participants Who Discontinued Study Drug Due To An AE [Time Frame: Up to 5 days]

Maximum log10 HCV Ribonucleic Acid (RNA) Change From Baseline [Time Frame: Baseline and up to Day 5]

Number of Participants Who Experienced One or More Adverse Events (AEs) [Time Frame: Up to 61 days]

Secondary ID(s)

MK-8408-003

8408-003

2013-005094-41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/11/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02076100