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

NCT01803373 | Completed Phase 1

• 3 other identifiers: CR100987TMC207TBC10022012-005492-13
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Biological Availability

Keywords

Healthy; Biological Availability; Bioavailability; TMC207; Bedaquiline; R207910

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of TMC207

  Protocol-specified pharmacokinetic parameters will be determined from plasma samples collected after each administration of study drug to assess the relative bioavailability of TMC207.

  Up to 72 hours after study drug intake during 3 treatment sessions

Secondary Outcomes (4)

• The plasma concentration of the primary metabolite in TMC207

  Up to 72 hours after each study drug intake during 3 treatment sessions

• The effect of food on the relative bioavailability of TMC207

  Up to 72 hours after study drug intake during 3 treatment sessions

• The number of participants reporting adverse events as a measure of safety and tolerability

  Up to approximately 12.5 weeks

• The taste of TMC207

  On Day 1 after study drug administration during 3 treatment sessions.

Study Arms (6)

Treatment Sequence ABC

EXPERIMENTAL

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); Drug: Treatment B; Drug: Treatment C

Treatment Sequence ACB

EXPERIMENTAL

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); Drug: Treatment B; Drug: Treatment C

Treatment Sequence BAC

EXPERIMENTAL

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); Drug: Treatment B; Drug: Treatment C

Treatment Sequence BCA

EXPERIMENTAL

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); Drug: Treatment B; Drug: Treatment C

Treatment Sequence CBA

EXPERIMENTAL

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); Drug: Treatment B; Drug: Treatment C

Treatment Sequence CAB

EXPERIMENTAL

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); Drug: Treatment B; Drug: Treatment C

Interventions

Treatment A (reference) DRUG

One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.

Treatment Sequence ABC; Treatment Sequence ACB; Treatment Sequence BAC; Treatment Sequence BCA; Treatment Sequence CAB; Treatment Sequence CBA

Treatment B DRUG

Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.

Treatment Sequence ABC; Treatment Sequence ACB; Treatment Sequence BAC; Treatment Sequence BCA; Treatment Sequence CAB; Treatment Sequence CBA

Treatment C DRUG

5 grams (ie,20mg/g) equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.

Treatment Sequence ABC; Treatment Sequence ACB; Treatment Sequence BAC; Treatment Sequence BCA; Treatment Sequence CAB; Treatment Sequence CBA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Infectious Diseases BVBA: lead

Study Sites (1)

Unknown Facility

Groningen, Netherlands

Location

Study Officials

• Janssen Infectious Diseases BVBA Clinical Trial

  Janssen Infectious Diseases BVBA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 4, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

NL (1)