A Open-label Study to Evaluate the Relative Bioavailability of Samatasvir (IDX184) and Food Effect in Healthy Male Participants (MK-2355-006)
- Registration Number
- NCT01335607
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A: Samatasvir cap→tab→tab; Part B: cap Samatasvir capsule Part A: Samatasvir capsule as a single dose on Day 1 (fasting state) followed by samatasvir tablet as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state) Part A: Samatasvir tab→cap→tab; Part B: cap Samatasvir tablet Part A: Samatasvir tablet as a single dose on Day 1 (fasting state) followed by samatasvir capsule as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state) Part A: Samatasvir tab→cap→tab; Part B: cap Samatasvir capsule Part A: Samatasvir tablet as a single dose on Day 1 (fasting state) followed by samatasvir capsule as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state) Part A: Samatasvir cap→tab→tab; Part B: cap Samatasvir tablet Part A: Samatasvir capsule as a single dose on Day 1 (fasting state) followed by samatasvir tablet as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state)
- Primary Outcome Measures
Name Time Method 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: 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: 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: 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 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 Outcome Measures
Name Time Method 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