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A Study to Assess the Relative Bioavailability of TMC207 Following Single-Dose Administrations of Two Pediatric Formulations in Healthy Adult Participants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01803373
First Posted: March 4, 2013
Last Update Posted: March 18, 2014
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.
Information provided by (Responsible Party):
Janssen Infectious Diseases BVBA
  Purpose
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.

Condition Intervention Phase
Healthy Biological Availability Drug: Treatment A (reference) Drug: Treatment B Drug: Treatment C Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Janssen Infectious Diseases BVBA:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • The plasma concentration of the primary metabolite in TMC207 [ Time Frame: Up to 72 hours after each 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 concentration of the primary metabolite in TMC207.

  • 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).

  • The number of participants reporting adverse events as a measure of safety and tolerability [ Time Frame: Up to approximately 12.5 weeks ]
    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).

  • The taste of TMC207 [ Time Frame: On Day 1 after study drug administration during 3 treatment sessions. ]
    The taste of each formulation will be assessed by having study participants complete a 5-item questionnaire after they take study drug.


Enrollment: 36
Study Start Date: April 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Treatment A (reference)
One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Drug: Treatment B
Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Drug: Treatment C
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.
Drug: Treatment A (reference)
One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Drug: Treatment B
Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Drug: Treatment C
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.
Drug: Treatment A (reference)
One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Drug: Treatment B
Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Drug: Treatment C
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.
Drug: Treatment A (reference)
One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Drug: Treatment B
Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Drug: Treatment C
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.
Drug: Treatment A (reference)
One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Drug: Treatment B
Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Drug: Treatment C
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.
Drug: Treatment A (reference)
One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Drug: Treatment B
Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
Drug: Treatment C
5 grams (ie,20mg/g) equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.

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).
  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01803373


Locations
Netherlands
Groningen, Netherlands
Sponsors and Collaborators
Janssen Infectious Diseases BVBA
Investigators
Study Director: Janssen Infectious Diseases BVBA Clinical Trial Janssen Infectious Diseases BVBA
  More Information

Responsible Party: Janssen Infectious Diseases BVBA
ClinicalTrials.gov Identifier: NCT01803373     History of Changes
Other Study ID Numbers: CR100987
TMC207TBC1002 ( Other Identifier: Janssen Infectious Diseases BVBA )
2012-005492-13 ( EudraCT Number )
First Submitted: March 1, 2013
First Posted: March 4, 2013
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by Janssen Infectious Diseases BVBA:
Healthy
Biological Availability
Bioavailability
TMC207
Bedaquiline
R207910

Additional relevant MeSH terms:
Bedaquiline
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents