A Phase 1 interventional study of TMC435 HPMC capsule and TMC435 HPMC or gelatin capsule in Hepatitis C, sponsored by Tibotec Pharmaceuticals, Ireland. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-11.
Sponsored by Tibotec Pharmaceuticals, Ireland · Phase 1, Interventional, and Treatment
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.
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.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 48 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Tibotec Pharmaceuticals, Ireland is the lead sponsor of 75 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TMC435 gelatin capsule Single intake of one 150-mg capsule without food
Drug: TMC435 gelatin capsule
TMC435 HPMC capsule Single intake of one 150-mg capsule without food
Drug: TMC435 HPMC capsule
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule without food
Drug: TMC435 HPMC or gelatin capsule
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after standardized breakfast
Drug: TMC435 HPMC or gelatin capsule
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after high-fat breakfast
Drug: TMC435 HPMC or gelatin capsule
Single intake of one 150-mg capsule without food
Single intake of one 150-mg capsule after high-fat breakfast
Single intake of one 150-mg capsule without food
Single intake of one 150-mg capsule after standardized breakfast
Single intake of one 150-mg capsule without food
Absorption of TMC435 following administration of the HPMC capsule and of the gelatin capsule
Time frame: 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
Time frame: Over 72 hours for every treatment session
Number of participants with adverse events and the severity of adverse events
Time frame: During maximum 7 weeks
Percentage of abnormal values for laboratory parameters
Time frame: Up to maximum 7 weeks
Observed values and changes from baseline of cardiovascular variables
Time frame: 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
Time frame: Up to maximum 7 weeks
Physical examination findings and changes from baseline.
Time frame: Up to maximum 7 weeks
No study locations are listed for this record.
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Tibotec Pharmaceuticals, Ireland