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Sponsored by: |
Tibotec Pharmaceuticals Limited, Ireland |
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Information provided by: | Tibotec Pharmaceuticals Limited, Ireland |
ClinicalTrials.gov Identifier: | NCT00752648 |
The objectives are: to compare the oral bioavailability and plasma pharmacokinetics of TMC435350 for 2 different solid formulations to those of TMC435350 formulated as a powder blend in a capsule, after a single oral dose of 200 mg in healthy volunteers; to determine the short term safety and tolerability of TMC435350 after a single oral dose of 200 mg formulated in capsules with 2 different formulations and as a tablet in healthy volunteers
Condition | Intervention | Phase |
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HCV Hepatitis C |
Drug: TMC435350 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-availability Study |
Official Title: | A Phase I, Open-Label, 3-Way Crossover Trial in Healthy Subjects to Compare the Bioavailability of a Single Oral Dose of TMC435350 Formulated as 2 Different Solid Formulations to That of a Single Oral Dose of TMC435350 Formulated as a Powder Blend Capsule |
Estimated Enrollment: | 12 |
Study Start Date: | July 2008 |
This is a Phase I, open-label, 3-way crossover trial in 12 healthy adult volunteers to compare the oral bioavailability of a single 200 mg intake of TMC435350 salt, formulated as 2 different solid formulations (a tablet and a capsule) to that of a single 200 mg intake of TMC435350 salt, formulated as a powder blend in a capsule. TMC435350 is a protease inhibitor in development for treatment of chronic hepatitis C virus (HCV) infection. During 3 sessions, each volunteer will receive 3 treatments according to a classical 6-sequence, 3-period Williams design.The treatments administered are: Treatment A: single dose of 200 mg TMC435350 salt, formulated as a powder blend filled in a capsule. Treatment B: single dose of 200 mg TMC435350 salt, formulated in a tablet. Treatment C: single dose of 200 mg. MC435350 salt, formulated in beads filled in a capsule. All medication intakes will be oral and under fed conditions. There will be a washout period of at least 7 days between medication intakes in subsequent treatment sessions. Full pharmacokinetic profiles of TMC435350 will be determined up to 72 hours after administration in each session. Safety and tolerability will be monitored continuously throughout the trial.
Treatments A, B and C: TMC435350 200mg on Day 1 of each session.Intakes will be oral and in fed conditions.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Antwerp, Belgium, 2060 |
Study Director: | Tibotec Pharmaceuticals Limited Clinical Trial | Tibotec Pharmaceuticals Limited, Ireland |
Study ID Numbers: | CR015415 |
Study First Received: | September 11, 2008 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00752648 |
Health Authority: | Ireland: Irish Agriculture and Food Development Authority |
TMC435350-C106 Pharmacokinetics TMC435350-TiDP16-C106 Bioavailability |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Healthy Hepatitis C |
RNA Virus Infections Flaviviridae Infections |