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

NCT01335607 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-01-26

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

DRUG

Samatasvir tablet

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

DRUG

Samatasvir capsule

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-05-31
Completion
2011-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335607 on ClinicalTrials.gov