Healthy VolunteerPhase 1NCT01291563
TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed Conditions
A Phase 1 study testing Moxifloxacin and TMC207 in people with Healthy Volunteer, run by Tibotec BVBA.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Moxifloxacin and TMC207
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteer
- Being tested
- Moxifloxacin, TMC207, TMC207 placebo, Moxifloxacin placebo
- Keywords
- TMC207TBC1003, TMC207, M.Tuberculosis, TBC, Moxifloxacin, ECG, QT/QTc, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
1 capsule of moxifloxacin (400 mg/capsule) on Day 2
TMC207Drug
8 tablets of TMC207 (100 mg/tablet) on Day 1
TMC207 placeboDrug
8 tablets of TMC207 placebo on Day 1
Moxifloxacin placeboDrug
1 capsule of moxifloxacin placebo on Day 2
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | TMC207 8 tablets of TMC207 (100 mg/tablet) on Day 1 Receives: Drug: TMC207 |
| 002 | Placebo comparator | TMC207 placebo 8 tablets of TMC207 placebo on Day 1 Receives: Drug: TMC207 placebo |
| 003 | Active comparator | Moxifloxacin 1 capsule of moxifloxacin (400 mg/capsule) on Day 2 Receives: Drug: Moxifloxacin |
| 004 | Placebo comparator | Moxifloxacin placebo 1 capsule of moxifloxacin placebo on Day 2 Receives: Drug: Moxifloxacin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG evaluation as a measure of QT and QTc interval
Measured: Measured Day -1 to Day 3
Secondary outcomes (4)
ECG evaluation as a measure of non-QT interval electrocardiogram parameters (RR interval, HR, PR and QRS interval)
Measured: Measured on Day -1 until Day 3
Plasma concentrations of TMC207 and its N-monodesmethyl metabolite (M2)
Measured: Measured on Day -1 until Day 3
Evaluation of the concentration-effect relationship for QT/QTc for TMC207 and M2
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibotec-Virco Virology BVBA Clinical Trial, Study director, Tibotec BVBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291563
- Sponsor's protocol ID
- CR017167
- Other IDs
- TMC-207-TBC1003
- Status last verified
- Nov 2012
- First submitted
- 1 Feb 2011
- Last updated
- 6 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01291563
- Acronym / sponsor ID
- CR017167
- Conditions
- Healthy Volunteer
- Keywords
- TMC207TBC1003, TMC207, M.Tuberculosis, TBC, Moxifloxacin, ECG, QT/QTc, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Tibotec BVBAIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: TMC207TMC207 8 tablets of TMC207 (100 mg/tablet) on Day 1 |
| 002 | Placebo comparator | Drug: TMC207 placeboTMC207 placebo 8 tablets of TMC207 placebo on Day 1 |
| 003 | Active comparator | Drug: MoxifloxacinMoxifloxacin 1 capsule of moxifloxacin (400 mg/capsule) on Day 2 |
| 004 | Placebo comparator | Drug: Moxifloxacin placeboMoxifloxacin placebo 1 capsule of moxifloxacin placebo on Day 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin1 capsule of moxifloxacin (400 mg/capsule) on Day 2 | Drug | 003 |
| TMC2078 tablets of TMC207 (100 mg/tablet) on Day 1 | Drug | 001 |
| TMC207 placebo8 tablets of TMC207 placebo on Day 1 | Drug | 002 |
| Moxifloxacin placebo1 capsule of moxifloxacin placebo on Day 2 | Drug | 004 |
Primary outcome
ECG evaluation as a measure of QT and QTc interval
Time frame: Measured Day -1 to Day 3
4 secondary outcomes
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
Plasma concentrations of TMC207 and its N-monodesmethyl metabolite (M2)
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tibotec-Virco Virology BVBA Clinical Trial study director
Tibotec BVBA
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moxifloxacin and TMC207 in people with Healthy Volunteer, run by Tibotec BVBA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG evaluation as a measure of QT and QTc interval (time frame: Measured Day -1 to Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2012.