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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: Samatasvir capsule; Drug: Samatasvir tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01335607

IDX-08C-006 (Other Identifier)

2355-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Male

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

12 participants in 2 patient groups

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

Active Comparator group

Description:

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)

Treatment:

Drug: Samatasvir capsule

Drug: Samatasvir tablet

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

Active Comparator group

Description:

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)

Treatment:

Drug: Samatasvir capsule

Drug: Samatasvir tablet