Phase 1 Completed N=22 Treatment

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

Hepatitis C Infection

Source: ClinicalTrials.gov NCT02076100 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcomePrimary: Maximum log10 HCV Ribonucleic Acid (RNA) Change From Baseline — 2.84; 3.03; 3.36; 1.81 log10 IU/mL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum log10 HCV Ribonucleic Acid (RNA) Change From Baseline	2.84; 3.03; 3.36; 1.81; 3.82; 3.62	—
PRIMARY Number of Participants Who Experienced One or More Adverse Events (AEs)	0; 0; 2; 1; 2; 2	—
PRIMARY Number of Participants Who Discontinued Study Drug Due To An AE	0; 0; 0; 0; 0; 0	—

Eligibility Criteria

Inclusion Criteria

Body mass index (BMI) >=18 to =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)

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Data sourced from ClinicalTrials.gov (NCT02076100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.