TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect Study

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare absorption of TMC435 formulated as 2 different types of capsules. After that, the absorption of one chosen TMC435 capsule will be compared when taken under fasting conditions or together with a standard or a high-fat meal. This will be done in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Simeprevir

Criteria

Inclusion Criteria:

• Non-smokers for at least 3 months prior to screening

• Have a body mass index of 18.0 to 30.0 kg per square meter

• Be healthy on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening

Exclusion Criteria:

• Use of disallowed therapies, including over-the-counter products and dietary supplements

• Having previously participated in a multiple-dose trial or more than 3 single-dose trials with TMC435

• Received an investigational drug or used an investigational medical device within 90 days before the planned start of treatment

• History or evidence of current use of alcohol, barbiturate, amphetamine, recreational, or narcotic drug use