- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01134718
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
April 8, 2013 updated by: Tibotec Pharmaceuticals, Ireland
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
24
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
TMC435 (F021) one morning dose of 150 mg
|
one morning dose of 150 mg
|
Experimental: 002
TMC435 (G006) one morning dose of 150 mg
|
one morning dose of 150 mg
|
Experimental: 003
TMC435 (G007) one morning dose of 150 mg
|
one morning dose of 150 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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
Outcome Measure |
Time Frame |
---|---|
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
|
Till last follow up safety visit 4-5 weeks after last intake of study medication
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
May 28, 2010
First Submitted That Met QC Criteria
May 28, 2010
First Posted (Estimate)
June 2, 2010
Study Record Updates
Last Update Posted (Estimate)
April 9, 2013
Last Update Submitted That Met QC Criteria
April 8, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis
- Hepatitis C
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Simeprevir
Other Study ID Numbers
- CR017155
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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