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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01134718
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : April 9, 2013
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Drug: TMC435 (G006) Drug: TMC435 (F021) Drug: TMC435 (G007) Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Simeprevir
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 001
TMC435 (F021) one morning dose of 150 mg
Drug: TMC435 (F021)
one morning dose of 150 mg
Experimental: 002
TMC435 (G006) one morning dose of 150 mg
Drug: TMC435 (G006)
one morning dose of 150 mg
Experimental: 003
TMC435 (G007) one morning dose of 150 mg
Drug: TMC435 (G007)
one morning dose of 150 mg

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01134718

Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited

Responsible Party: Tibotec Pharmaceuticals, Ireland Identifier: NCT01134718     History of Changes
Other Study ID Numbers: CR017155
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: April 9, 2013
Last Verified: April 2013

Keywords provided by Tibotec Pharmaceuticals, Ireland:
Protease inhibitor
Hepatitis C

Additional relevant MeSH terms:
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action