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

Tibotec Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: TMC435 HPMC or gelatin capsule; Drug: TMC435 gelatin capsule; Drug: TMC435 HPMC capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01308606

TMC435-TiDP16-C116

CR015940

Details and patient eligibility

About

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.

Full description

This is an open-label, randomized, single-dose, crossover trial in healthy volunteers. Crossover means that participants may receive different interventions sequentially during the trial. Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin. Open-label means that you and your physician will know what treatment you will receive. The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase. Total study duration for an individual participant will be up to 6 or 7 weeks. Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase. In the first part, a group of 24 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance. Treatment A is a single dose of TMC345 as one formulation (1 capsule). Treatment B is a single dose of TMC435 as another formulation (1 other type of capsule). Both treatments will be taken without food. In between the 2 sessions, there will be at least 7 days. In the second part, another group of 24 participants will receive 3 treatment sessions, C, D, and E. The order in which these treatments are given will be determined by chance. All 3 treatments will consist of a single dose of TMC435 as one of the 2 formulations given in the first part. In Treatment C this will be given without food, in Treatment D with a standardized breakfast and in Treatment E with a high-fat breakfast. In between the sessions, there will be at least 7 days. For all treatment sessions, participants will enter the study center the day before dosing and will remain there until the evening of the day after. The 3 following mornings, participants will come back to the study center. Five to 7 days after dosing, participants will have a last follow-up visit at the study center (follow-up phase). During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drug). In every treatment session, a single oral 150 mg TMC435 capsule will be given. One formulation will be a gelatin capsule. The other formulation will be a hydroxypropylmethylcellulose (HPMC) capsule.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 5 patient groups

001

Experimental group

Description:

TMC435 gelatin capsule Single intake of one 150-mg capsule without food

Treatment:

Drug: TMC435 gelatin capsule

002

Experimental group

Description:

TMC435 HPMC capsule Single intake of one 150-mg capsule without food

Treatment:

Drug: TMC435 HPMC capsule

003

Experimental group

Description:

TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule without food

Treatment:

Drug: TMC435 HPMC or gelatin capsule

Drug: TMC435 HPMC or gelatin capsule

Drug: TMC435 HPMC or gelatin capsule

004

Experimental group

Description:

TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after standardized breakfast

Treatment:

Drug: TMC435 HPMC or gelatin capsule

Drug: TMC435 HPMC or gelatin capsule

Drug: TMC435 HPMC or gelatin capsule

005

Experimental group

Description:

TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after high-fat breakfast

Treatment:

Drug: TMC435 HPMC or gelatin capsule

Drug: TMC435 HPMC or gelatin capsule

Drug: TMC435 HPMC or gelatin capsule