A Open-label Study to Evaluate the Relative Bioavailability of Samatasvir (IDX184) and Food Effect in Healthy Male Participants (MK-2355-006)

NCT ID: NCT01335607

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-05-31

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Part A: Samatasvir cap→tab→tab; Part B: cap

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)

Group Type: ACTIVE_COMPARATOR

Samatasvir tablet

Intervention Type: DRUG

Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)

Samatasvir capsule

Intervention Type: DRUG

Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)

Part A: Samatasvir tab→cap→tab; Part B: cap

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)

Group Type: ACTIVE_COMPARATOR

Samatasvir tablet

Intervention Type: DRUG

Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)

Samatasvir capsule

Intervention Type: DRUG

Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)

Interventions

Samatasvir tablet

Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)

Intervention Type: DRUG

Samatasvir capsule

Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

IDX-08C-006

Identifier Type: OTHER

Identifier Source: secondary_id

2355-006

Identifier Type: -

Identifier Source: org_study_id