Hepatitis C
Conditions
Keywords
HCV, Hepatitis C Virus
Brief summary
The purpose of this study is to: * Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and tablet prototype test formulation) * Compare the amount of study drug that is in the blood after taking either the capsule form of the drug or the tablet form of the drug while fasting. * Determine the amount of study drug that is in the blood after eating a meal. * Evaluate the safety of the tablet form of samatasvir in healthy people.
Detailed description
Each participant will receive each of the formulations in a crossover design. Part A Periods 1 and 2: Participants will receive either samatasvir capsules or tablets according to randomization under fasting conditions on Days 1 and 8. Part A Period 3: All participants will receive samatasvir tablets under fed conditons on Day 15. Each dose will be separated by a 7-day wash-out period. Part B: All participants will receive samatasvir capsules under fed conditons on Day 1.
Interventions
DRUGSamatasvir tablet
Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)
DRUGSamatasvir capsule
Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be a healthy male with body mass index (BMI) between 18 and 35 kg/m * Must agree to use an acceptable double-barrier method of birth control. * Must provide written informed consent after the study has been fully explained.
Exclusion criteria
* History of clinically significant diseases, as determined by the investigator. * Safety laboratory abnormalities at screening which are clinically significant. * Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV). * Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study. * Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameter: Observed maximum plasma drug concentration (Cmax) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours |
| Pharmacokinetic parameter: Time to maximum concentration (Tmax) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours |
| Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to last measurable concentration (AUC 0-t) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours |
| Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to 24 hours (AUC 0-24) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours |
| Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to infinity (AUC 0-infinity) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours |
| Pharmacokinetic parameter: Plasma concentration at 24 hours post dose (C24h) | 24 hours |
| Pharmacokinetic parameter: Observed plasma terminal half-life (T1/2) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours |
| Pharmacokinetic parameter: Apparent oral total plasma clearance (CL/F) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours |
| Pharmacokinetic parameter: Apparent oral total plasma volume of distribution (Vz/F) | Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants who experienced an adverse event | Up to Day 20 |
| Percentage of participants who experienced a serious adverse event | Up to Day 20 |
| Percentage of participants who experienced a Grade 1-4 laboratory abnormality | Up to Day 20 |
Outcome results
None listed