Phase I, Open-label Trial in Healthy Subjects to Evaluate the Drug-drug Interaction Between Ritonavir at Steady-state and TMC435350, a Viral Protease Inhibitor Against Hepatitis C Virus, After the First and the Last Dose of a Multiple Dosing Regimen
Sponsor study identifier
Secondary identifiers
OTHER · Tibotec Pharmaceuticals Limited, Ireland
interventional
12
1 country
1
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2008
Actual (reported)Study Completion
January 2008
Actual (reported)The purpose of this study is to evaluate the drug-drug interaction between steady-state concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the multiple dosing regimen and to explore the short term safety and tolerability of multiple doses of 200 mg of TMC435350 administered alone and in combination with 100 mg of ritonavir.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
January 2008
Actual (reported)January 2008
Actual (reported)June 28, 2013
Actual (reported)July 3, 2013
Actual (reported)Plasma concentration of TMC435350
In Session 1, the plasma concentration of TMC435350 is measured in the absence of ritonavir.
Days 1 and 7 of Session 1
Plasma concentration of TMC435350
In Session 2, the plasma concentration of TMC435350 is measured in the presence of ritonavir.
Days 6 and 16 of Session 2
Number of patients reporting adverse events (AEs) as a measure of safety and tolerability
Up to approximately 86 days
TMC435350 2 capsules of 100-mg twice daily / Ritonavir one 100-mg capsule twice daily
Each patient will receive 200 mg (2 capsules) once daily orally from Day 1 to Day 7 in Session 1 and from Day 6 to Day 12 in Session 2
Each patient will receive 100 mg (1 capsule) of ritonavir twice daily orally from Day 1 until Day 15 of Session 2
Aalst, Belgium
Tibotec Pharmaceuticals Limited, Ireland Clinical Trial
Tibotec Pharmaceuticals, Ireland
12 participants (actual enrollment reported by the registry).
First Submitted
June 28, 2013
First Posted
July 3, 2013
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2008
Actual (reported)Study Completion
January 2008
Actual (reported)Last Updated
October 14, 2013
Record last verified: 2013-10
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Source: ClinicalTrials.gov.
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