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TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed Conditions

NCT ID: NCT01291563

Last Updated: 2012-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study is to evaluate the effect of an 800-mg single dose of TMC207 on the QT/QTc interval in healthy volunteers.

Detailed Description

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TMC207 is being investigated for the treatment of M. Tuberculosis (MTB, formerly known as TBC) infection. This study is designed to establish the effect of a single dose of TMC207 on the QT/QTc interval in healthy volunteers under fed conditions. This is a Phase I, double-blind (study doctor nor participants will know which treatment will be received), randomized (study medication is assigned by chance, like tossing a coin), placebo- and active-controlled study to evaluate the effect of single-dose TMC207 on the QT/QTc interval in healthy volunteers. A single dose of 400 mg moxifloxacin will be used as a positive control to assess trial sensitivity. The trial population will consist of 88 healthy volunteers. Forty-four participants will be randomized to Group 1, and 22 participants will be randomized to each of the Groups 2 and 3. Each gender should be represented by at least 40%. Each participant will receive one of the Treatments A or B in one treatment session. Participants in Group 1 will take a single 800-mg dose of TMC207 on Day 1 and a single dose of moxifloxacin placebo on Day 2 (Treatment A). Participants in Groups 2 and 3 will take a single dose of TMC207 placebo on Day 1 and a single 400-mg dose of moxifloxacin on Day 2 (Treatment B). All intakes of TMC207, moxifloxacin, TMC207 placebo and moxifloxacin placebo will be taken with standardized meals. The duration of the study will be 3 days, screening and follow-up period not included. On Days -1, 1, and 2 of Treatment A and B, electrocardiograms (ECGs) will be recorded continuously for 24 hours per day by Holter monitoring. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a similar schedule and will be performed during each treatment period, up to 4 weeks after the last study drug intake.The pharmacokinetic characteristics (level-profile of TMC207 and moxifloxacin over time in the blood stream) will be evaluated by multiple blood samples from Day -1 tol Day 3. Participants in Group 1 will take a single 800-mg dose of TMC207 on Day 1 and a single dose of moxifloxacin placebo on Day 2 (Treatment A). Participants in Groups 2 and 3 will take a single dose of TMC207 placebo on Day 1 and a single 400-mg dose of moxifloxacin on Day 2 (Treatment B).¿ The study duration will be 3 days without screening and follow-up period included.

Conditions

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Healthy Volunteer

Keywords

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TMC207TBC1003 TMC207 M.Tuberculosis TBC Moxifloxacin ECG QT/QTc Healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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001

TMC207 8 tablets of TMC207 (100 mg/tablet) on Day 1

Group Type EXPERIMENTAL

TMC207

Intervention Type DRUG

8 tablets of TMC207 (100 mg/tablet) on Day 1

002

TMC207 placebo 8 tablets of TMC207 placebo on Day 1

Group Type PLACEBO_COMPARATOR

TMC207 placebo

Intervention Type DRUG

8 tablets of TMC207 placebo on Day 1

003

Moxifloxacin 1 capsule of moxifloxacin (400 mg/capsule) on Day 2

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

1 capsule of moxifloxacin (400 mg/capsule) on Day 2

004

Moxifloxacin placebo 1 capsule of moxifloxacin placebo on Day 2

Group Type PLACEBO_COMPARATOR

Moxifloxacin placebo

Intervention Type DRUG

1 capsule of moxifloxacin placebo on Day 2

Interventions

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Moxifloxacin

1 capsule of moxifloxacin (400 mg/capsule) on Day 2

Intervention Type DRUG

TMC207

8 tablets of TMC207 (100 mg/tablet) on Day 1

Intervention Type DRUG

TMC207 placebo

8 tablets of TMC207 placebo on Day 1

Intervention Type DRUG

Moxifloxacin placebo

1 capsule of moxifloxacin placebo on Day 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram, and clinical laboratory tests at screening
* A Body Mass Index of 18.0 to 28.0 kg/m2, extremes included
* Women must be postmenopausal for at least two years, be surgically sterile and must have negative serum pregnancy test at screening
* Non-smoking for at least three months prior to selection.

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
* Previously participated in a TMC207 trial or received an investigational drug or vaccine within 60 days before the planned start of treatment
* A positive urine drug test at screening
* Volunteers with a clinically significant ECG abnormality or any other cardiac history (unusual T wave morphology, history of additional risk for Torsade de Pointes, electrolyte abnormalities, blood pressure outside of the normal range, or history of a clinically relevant heart rhythm disturbance or with a family history of Long QT Syndrome)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tibotec BVBA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tibotec-Virco Virology BVBA Clinical Trial

Role: STUDY_DIRECTOR

Tibotec BVBA

Other Identifiers

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TMC-207-TBC1003

Identifier Type: -

Identifier Source: secondary_id

CR017167

Identifier Type: -

Identifier Source: org_study_id