- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01291563
TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed Conditions
November 5, 2012 updated by: Tibotec BVBA
A Double-blind, Randomized, Placebo- and Active-controlled, Parallel-group Trial to Evaluate the Effect of Single-dose TMC207 on the QT/QTc Interval in Healthy Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
88
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
No
Genders Eligible for Study
All
Description
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)
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: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
TMC207 8 tablets of TMC207 (100 mg/tablet) on Day 1
|
8 tablets of TMC207 (100 mg/tablet) on Day 1
|
Placebo Comparator: 002
TMC207 placebo 8 tablets of TMC207 placebo on Day 1
|
8 tablets of TMC207 placebo on Day 1
|
Active Comparator: 003
Moxifloxacin 1 capsule of moxifloxacin (400 mg/capsule) on Day 2
|
1 capsule of moxifloxacin (400 mg/capsule) on Day 2
|
Placebo Comparator: 004
Moxifloxacin placebo 1 capsule of moxifloxacin placebo on Day 2
|
1 capsule of moxifloxacin placebo on Day 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ECG evaluation as a measure of QT and QTc interval
Time Frame: Measured Day -1 to Day 3
|
Measured Day -1 to Day 3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ECG evaluation as a measure of non-QT interval electrocardiogram parameters (RR interval, HR, PR and QRS interval)
Time Frame: Measured on Day -1 until Day 3
|
Measured on Day -1 until Day 3
|
Plasma concentrations of TMC207 and its N-monodesmethyl metabolite (M2)
Time Frame: Measured on Day -1 until Day 3
|
Measured on Day -1 until Day 3
|
Evaluation of the concentration-effect relationship for QT/QTc for TMC207 and M2
Time Frame: Measured on Day -1 until Day 3
|
Measured on Day -1 until Day 3
|
Evaluation of the number of volunteers with adverse events, blood and urine tests, blood pressure and pulse tests, and ECGs as measures of safety and tolerability
Time Frame: Measured on Day -1 until Day 3 and Day 8-10 and 30 to 32 days after last study drug intake as safety follow up
|
Measured on Day -1 until Day 3 and Day 8-10 and 30 to 32 days after last study drug intake as safety follow up
|
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
February 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
February 1, 2011
First Submitted That Met QC Criteria
February 5, 2011
First Posted (Estimate)
February 8, 2011
Study Record Updates
Last Update Posted (Estimate)
November 6, 2012
Last Update Submitted That Met QC Criteria
November 5, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Antitubercular Agents
- Moxifloxacin
- Norgestimate, ethinyl estradiol drug combination
- Bedaquiline
- Diarylquinolines
Other Study ID Numbers
- CR017167
- TMC-207-TBC1003
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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