Trial Outcomes & Findings for Safety, Pharmacokinetics, and Pharmacodynamics of Ruzasvir (MK-8408) in Participants With Hepatitis C Infection (MK-8408-003) (NCT NCT02076100)

NCT ID: NCT02076100

Last Updated: 2018-12-24

Results Overview

Blood was collected at baseline and on Days 1, 2, 3, 4 and 5 to determine HCV RNA levels. Least squares means (LSM) and confidence intervals (CI) were obtained from an analysis of variance (ANOVA) model with maximum log10 HCV RNA change from baseline as response and a fixed effect for treatment. The primary hypothesis was that the mean change from baseline would be a reduction of ≥3 log10. A positive change from baseline indicates a reduction from baseline in log10 HCV RNA.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

22 participants

Primary outcome timeframe

Baseline and up to Day 5

Results posted on

2018-12-24

Participant Flow

Males or females of non-child bearing potential, with verified Hepatitis C virus (HCV) infection with genotype (GT) GT1a, GT2b or GT3 between the ages of 18 and 65 years (inclusive) were enrolled in this trial. In the GT1a group, one participant was later determined to be GT1b.

Participant milestones

Participant milestones
Measure	Ruzasvir 10 mg - GT3 GT3 participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 30 mg - GT3 GT3 participants were administered 30 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT3 GT3 participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 120 mg - GT3 GT3 participants were administered 120 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 10 mg - GT2b GT2b participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT2b GT2b participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT1a GT1a participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days. One participant was later determined to be GT1b.
Overall Study STARTED	3	3	3	3	3	3	4
Overall Study COMPLETED	3	3	3	3	3	3	4
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ruzasvir 10 mg - GT3 n=3 Participants GT3 participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 30 mg - GT3 n=3 Participants GT3 participants were administered 30 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT3 n=3 Participants GT3 participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 120 mg - GT3 n=3 Participants GT3 participants were administered 120 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 10 mg - GT2b n=3 Participants GT2b participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT2b n=3 Participants GT2b participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT1a n=4 Participants GT1a participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days. One participant was later determined to be GT1b.	Total n=22 Participants Total of all reporting groups
Age, Continuous	40.7 Years STANDARD_DEVIATION 6.5 • n=5 Participants	36.0 Years STANDARD_DEVIATION 3.5 • n=7 Participants	38.0 Years STANDARD_DEVIATION 10.4 • n=5 Participants	40.7 Years STANDARD_DEVIATION 13.6 • n=4 Participants	56.3 Years STANDARD_DEVIATION 2.1 • n=21 Participants	54.0 Years STANDARD_DEVIATION 6.2 • n=10 Participants	48.5 Years STANDARD_DEVIATION 6.2 • n=115 Participants	45.0 Years STANDARD_DEVIATION 9.9 • n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	4 Participants n=115 Participants	19 Participants n=24 Participants

PRIMARY outcome

Timeframe: Baseline and up to Day 5

Population: Participants who complied with the protocol sufficiently to ensure that generated data would exhibit the effects of treatment, according to the underlying scientific model. Compliance covers considerations such as exposure to treatment, availability of measurements and absence of major protocol violations.

Outcome measures

Outcome measures
Measure	Ruzasvir 10 mg - GT3 n=3 Participants GT3 participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 30 mg - GT3 n=3 Participants GT3 participants were administered 30 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT3 n=3 Participants GT3 participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 120 mg - GT3 n=3 Participants GT3 participants were administered 120 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 10 mg - GT2b n=3 Participants GT2b participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT2b n=3 Participants GT2b participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT1a n=3 Participants GT1a participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT1b n=1 Participants A GT1b participant was administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
Maximum log10 HCV Ribonucleic Acid (RNA) Change From Baseline	2.84 log10 IU/mL Interval 1.94 to 3.74	3.03 log10 IU/mL Interval 2.13 to 3.94	3.36 log10 IU/mL Interval 2.46 to 4.26	1.81 log10 IU/mL Interval 0.9 to 2.71	3.82 log10 IU/mL Interval 3.15 to 4.5	3.62 log10 IU/mL Interval 2.95 to 4.3	3.63 log10 IU/mL Interval 2.46 to 4.81	3.82 log10 IU/mL Data reflect n=1 and therefore 90% CI was not calculable.

PRIMARY outcome

Timeframe: Up to 61 days

Population: All participants who received at least one dose of the investigational drug.

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Outcome measures

Outcome measures
Measure	Ruzasvir 10 mg - GT3 n=3 Participants GT3 participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 30 mg - GT3 n=3 Participants GT3 participants were administered 30 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT3 n=3 Participants GT3 participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 120 mg - GT3 n=3 Participants GT3 participants were administered 120 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 10 mg - GT2b n=3 Participants GT2b participants were administered 10 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT2b n=3 Participants GT2b participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT1a n=4 Participants GT1a participants were administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.	Ruzasvir 60 mg - GT1b A GT1b participant was administered 60 mg Ruzasvir in capsule form, orally, once per day for 5 days.
Number of Participants Who Experienced One or More Adverse Events (AEs)	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	2 Participants	2 Participants	—

PRIMARY outcome

Timeframe: Up to 5 days

Population: All participants who received at least one dose of the investigational drug.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.