- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01803373
A Study to Assess the Relative Bioavailability of TMC207 Following Single-Dose Administrations of Two Pediatric Formulations in Healthy Adult Participants
March 16, 2014 updated by: Janssen Infectious Diseases BVBA
A Phase I, Open-label, Randomized, 3-way Crossover Study in 3 Panels of Healthy, Adult Subjects to Assess the Relative Bioavailability of TMC207 Following Single-dose Administration of Two Pediatric Formulations Using a 100 mg Tablet Formulation as the Reference, With and Without Food.
The purpose of this study is to test the relative bioavailability (extent and rate to which a drug is taken up by the body) of TMC207 following the administration of two pediatric formulations of TMC207 taken with and without food in healthy adult participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-label (all study staff and participants know the identity of treatments assigned), 3-way cross-over (method used to switch participants from one treatment to another treatment) study.
Three panels of 12 healthy adult participants each will be enrolled.
Within each panel, participants will be randomly (by chance) assigned to 1 of 6 treatment sequences to receive each of the 3 formulations of TMC207 in a randomized order.
The 3 formulations of TMC207 will be referred to as Treatments A, B, and C. In Treatment A, participants will receive a single 100-mg dose of TMC207 formulated as a 100-mg tablet (reference formulation).
In Treatment B, participants will receive a single 100-mg dose of TMC207 formulated as 20-mg water dispersible (dissolvable) tablets (i.e. 5 tablets) (pediatric formulation 1).
In Treatment C, participants will receive a single 100-mg dose of TMC207 formulated as granules 5 grams (20 mg/g) (pediatric formulation 2).
Each treatment will be separated by 4 weeks.
Participants in Panel 1 will receive each treatment with a standardized breakfast, Panel 2 will receive each treatment with yogurt, and Panel 3 will receive each treatment after a 10-hour overnight fast (without food).
The duration of the treatment period in this study will be 8.5 weeks (includes 4 weeks between treatments).
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Groningen, Netherlands
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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:
- Healthy participant on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG), and the results of blood biochemistry and hematology tests and a urinalysis performed at screening
- Must have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included
- Women must be postmenopausal for at least 2 years and have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1
- Men must agree to use a highly effective method of birth control (eg., male condom with either female intrauterine device, diaphragm, cervical cap or hormone based contraceptives by their female partner) when having sexual intercourse with a female partner of childbearing potential, and to not donate sperm during the study and for 6 months after receiving the last dose of study drug. Men who have had a vasectomy and have a female partner of childbearing potential must agree to use a male condom during the study and for 6 months after receiving the last dose of study drug
- Participants must be non-smokers for at least 3 months prior to screening
Exclusion Criteria:
- Human immunodeficiency virus - type 1 (HIV-1) or type 2 (HIV-2) infection confirmed at screening
- Hepatitis A, B or C infection confirmed at screening
- A positive urine drug test or alcohol breath test at screening. Urine will be tested for the presence of amphetamines, barbiturates, benzodiazepines, cocaine, methadone, and opioids
- History or any currently active disease or condition that the Investigator considers to be clinically significant for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
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: Treatment Sequence ABC
Participants in Panel 1 will take the sequence of 3 treatments with a standardized breakfast, participants in Panel 2 will take the sequence of 3 treatments with yogurt, and participants in Panel 3 will take the sequence of 3 treatments after a 10-hour overnight fast (without food).
Each treatment in each treatment sequence to be separated by 4 weeks.
|
One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
5 grams (ie,20mg/g) equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
|
Experimental: Treatment Sequence ACB
Participants in Panel 1 will take the sequence of 3 treatments with a standardized breakfast, participants in Panel 2 will take the sequence of 3 treatments with yogurt, and participants in Panel 3 will take the sequence of 3 treatments after a 10-hour overnight fast (without food).
Each treatment in each treatment sequence to be separated by 4 weeks.
|
One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
5 grams (ie,20mg/g) equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
|
Experimental: Treatment Sequence BAC
Participants in Panel 1 will take the sequence of 3 treatments with a standardized breakfast, participants in Panel 2 will take the sequence of 3 treatments with yogurt, and participants in Panel 3 will take the sequence of 3 treatments after a 10-hour overnight fast (without food).
Each treatment in each treatment sequence to be separated by 4 weeks.
|
One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
5 grams (ie,20mg/g) equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
|
Experimental: Treatment Sequence BCA
Participants in Panel 1 will take the sequence of 3 treatments with a standardized breakfast, participants in Panel 2 will take the sequence of 3 treatments with yogurt, and participants in Panel 3 will take the sequence of 3 treatments after a 10-hour overnight fast (without food).
Each treatment in each treatment sequence to be separated by 4 weeks.
|
One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
5 grams (ie,20mg/g) equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
|
Experimental: Treatment Sequence CBA
Participants in Panel 1 will take the sequence of 3 treatments with a standardized breakfast, participants in Panel 2 will take the sequence of 3 treatments with yogurt, and participants in Panel 3 will take the sequence of 3 treatments after a 10-hour overnight fast (without food).
Each treatment in each treatment sequence to be separated by 4 weeks.
|
One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
5 grams (ie,20mg/g) equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
|
Experimental: Treatment Sequence CAB
Participants in Panel 1 will take the sequence of 3 treatments with a standardized breakfast, participants in Panel 2 will take the sequence of 3 treatments with yogurt, and participants in Panel 3 will take the sequence of 3 treatments after a 10-hour overnight fast (without food).
Each treatment in each treatment sequence to be separated by 4 weeks.
|
One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
5 grams (ie,20mg/g) equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma concentrations of TMC207
Time Frame: Up to 72 hours after study drug intake during 3 treatment sessions
|
Protocol-specified pharmacokinetic parameters will be determined from plasma samples collected after each administration of study drug to assess the relative bioavailability of TMC207.
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Up to 72 hours after study drug intake during 3 treatment sessions
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The plasma concentration of the primary metabolite in TMC207
Time Frame: Up to 72 hours after each study drug intake during 3 treatment sessions
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Protocol-specified pharmacokinetic parameters will be determined from plasma samples collected after each administration of study drug to assess the concentration of the primary metabolite in TMC207.
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Up to 72 hours after each study drug intake during 3 treatment sessions
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The effect of food on the relative bioavailability of TMC207
Time Frame: Up to 72 hours after study drug intake during 3 treatment sessions
|
The effect of food will be determined by comparing, across panels, each formulation taken after eating a standardized breakfast versus after eating yoghurt, and versus no food (ie, in the fasted state).
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Up to 72 hours after study drug intake during 3 treatment sessions
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The number of participants reporting adverse events as a measure of safety and tolerability
Time Frame: Up to approximately 12.5 weeks
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Includes up to 30-32 days after the last plasma sample in the last treatment session for participants who complete the study (or up to 30-32 days after a participant withdraws from the study).
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Up to approximately 12.5 weeks
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The taste of TMC207
Time Frame: On Day 1 after study drug administration during 3 treatment sessions.
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The taste of each formulation will be assessed by having study participants complete a 5-item questionnaire after they take study drug.
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On Day 1 after study drug administration during 3 treatment sessions.
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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
April 1, 2013
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
March 1, 2013
First Submitted That Met QC Criteria
March 1, 2013
First Posted (Estimate)
March 4, 2013
Study Record Updates
Last Update Posted (Estimate)
March 18, 2014
Last Update Submitted That Met QC Criteria
March 16, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- CR100987
- TMC207TBC1002 (Other Identifier: Janssen Infectious Diseases BVBA)
- 2012-005492-13 (EudraCT Number)
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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