Hepatitis C
Conditions
Keywords
TMC435-TiDP16-C116, TMC435-C116, TMC435, HCV, Hepatitis C, Hep C, healthy volunteers
Brief 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.
Detailed 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.
Interventions
DRUGTMC435 HPMC capsule
Single intake of one 150-mg capsule without food
DRUGTMC435 HPMC or gelatin capsule
Single intake of one 150-mg capsule after high-fat breakfast
DRUGTMC435 gelatin capsule
Single intake of one 150-mg capsule without food
Sponsors
Tibotec Pharmaceuticals, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absorption of TMC435 following administration of the HPMC capsule and of the gelatin capsule | Over 72 hours for every treatment session |
| Absorption of TMC435 following administration of the HPMC or gelatin capsule in the fed (following different meal types) and fasted state | Over 72 hours for every treatment session |
Secondary
| Measure | Time frame |
|---|---|
| Observed values and changes from baseline of cardiovascular variables | Up to maximum 7 weeks |
| Number of participants with adverse events and the severity of adverse events | During maximum 7 weeks |
| Physical examination findings and changes from baseline. | Up to maximum 7 weeks |
| Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits | Up to maximum 7 weeks |
| Percentage of abnormal values for laboratory parameters | Up to maximum 7 weeks |
Outcome results
None listed