Clinical trial NCT01335607: A Open-label Study to Evaluate the Relative Bioavailability of Samatasvir (IDX184) and Food Effect in Healthy Male Participants (MK-2355-006)
Official title: A Phase I, Open-label Study to Evaluate the Relative Bioavailability of IDX184 and Food Effect in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: HCV
Hepatitis C Virus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-04-14
Enrollment: 12
Sex: MALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetic parameter: Observed maximum plasma drug concentration (Cmax)
timeFrame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
measure: Pharmacokinetic parameter: Time to maximum concentration (Tmax)
timeFrame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
measure: Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to last measurable concentration (AUC 0-t)
timeFrame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
measure: Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to 24 hours (AUC 0-24)
timeFrame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours
measure: Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to infinity (AUC 0-infinity)
timeFrame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
measure: Pharmacokinetic parameter: Plasma concentration at 24 hours post dose (C24h)
timeFrame: 24 hours
measure: Pharmacokinetic parameter: Observed plasma terminal half-life (T1/2)
timeFrame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
measure: Pharmacokinetic parameter: Apparent oral total plasma clearance (CL/F)
timeFrame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
measure: Pharmacokinetic parameter: Apparent oral total plasma volume of distribution (Vz/F)
timeFrame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours
Secondary outcomes:
measure: Percentage of participants who experienced an adverse event
timeFrame: Up to Day 20
measure: Percentage of participants who experienced a serious adverse event
timeFrame: Up to Day 20
measure: Percentage of participants who experienced a Grade 1-4 laboratory abnormality
timeFrame: Up to Day 20
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: