TMC435-TiDP16-C119 - A Study Comparing 2 New Capsule Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Respective Blood Levels of TMC435 Following Single Dose Administration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT01134718
First received: May 28, 2010
Last updated: April 8, 2013
Last verified: April 2013

May 28, 2010
April 8, 2013
June 2010
August 2010   (final data collection date for primary outcome measure)
Rate and extent of absorption of TMC435 following administration of 3 different capsule formulations under fed condition [ Time Frame: Measured over a period of 4 consecutive days (Day1-Day4) per treatment. Treatments (3) are 7 days apart from each other. During 1st day of each treatment, 10 blood samples for determination of pharmacokinetic characteristics are taken. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01134718 on ClinicalTrials.gov Archive Site
All reported Adverse Events + percentage of subjects who experienced at least 1 occurrence of a given event as a measure of Safety and Tolerability following administration of single doses of 150 mg TMC435 [ Time Frame: Till last follow up safety visit 4-5 weeks after last intake of study medication ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
TMC435-TiDP16-C119 - A Study Comparing 2 New Capsule Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Respective Blood Levels of TMC435 Following Single Dose Administration
Pilot BA Study With Phase III/Commercial Versus Phase IIB Formulation. A Phase I, Open Label, Randomized, Single Dose, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of Potential Phase III Formulations Compared to the Phase IIb Capsule

The purpose of this study is to compare in healthy volunteers levels of TMC435 in the blood circulation after intake of 2 new capsule formulations with the level of TMC435 in the blood circulation after intake of the capsule formulation used in the Phase IIb studies.

This is a randomized (study drug assigned by chance), open-label (all people involved know the treatment), single dose, crossover (volunteers will receive different treatments sequentially during the trial) study in healthy volunteers. The trial will evaluate the levels of TMC435 in the blood circulation after a single dose of 150 mg TMC435 administered as 3 different capsule formulations following breakfast. There will be a 7-day washout period between treatments and a 4-5 week follow-up at the end. Each volunteer will receive all three treatments. The main focus of the trial is the pharmacokinetic characteristics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of the different formulations. This evaluation requires multiple blood samples from Day 1 through 72 hours after dosing. Safety assessments (lab work, blood pressure, pulse and electrocardiogram) will follow a different schedule and are measured on Day -1 (day prior to taking first dose of drug), Day 1 (without lab work) and Day 4 of each treatment period, and 1 and 4-5 weeks after the last treatment. Each volunteer will receive 3 treatments, 7 days apart from each other. Each treatment consists of one single oral dose of 150 mg TMC435.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C Virus
  • Drug: TMC435 (G006)
    one morning dose of 150 mg
  • Drug: TMC435 (F021)
    one morning dose of 150 mg
  • Drug: TMC435 (G007)
    one morning dose of 150 mg
  • Experimental: 001
    TMC435 (F021) one morning dose of 150 mg
    Intervention: Drug: TMC435 (F021)
  • Experimental: 002
    TMC435 (G006) one morning dose of 150 mg
    Intervention: Drug: TMC435 (G006)
  • Experimental: 003
    TMC435 (G007) one morning dose of 150 mg
    Intervention: Drug: TMC435 (G007)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-smoker for at least 3 months
  • Body Mass Index of 18.0 to 30.0 kg/m2
  • Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram

Exclusion Criteria:

  • Infection with Hepatitis A, B or C virus
  • Infection with the human immunodeficiency virus (HIV)
  • History of, or any current medical condition which could impact the safety of the participant in the study
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01134718
CR017155
No
Tibotec Pharmaceuticals, Ireland
Tibotec Pharmaceuticals, Ireland
Not Provided
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
Tibotec Pharmaceuticals, Ireland
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP