HealthyPhase 1NCT00946842
A Study to Determine the Relative Oral Bioavailability of Single Dose Administration of TMC207, Under Fed and Fasted Conditions in Healthy Participants
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Healthy, run by Tibotec BVBA.
Trial summary
The purpose of this study is to determine the relative oral bioavailability (the extent to which a medication or other substance becomes available to the body as compared with another form of medication or other substance) of TMC207 after single-dose oral administration of the Phase II clinical study tablet… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Treatment A, Treatment B and Treatment C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Mar 2010
- 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
- Non-smoker or smokers with no more than 10 cigarettes or 2 cigars or 2 pipes per day for at least 3 months prior selection
- Normal weight as defined by a body mass index (weight in kilograms divided by the square of height in meters) of 18 to 30 kg/m2, extremes included
- Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality
Who cannot join
- Positive tests for Human Immunodeficiency Virus 1 (HIV type 1) or HIV 2; hepatitis A, hepatitis B, or hepatitis C infection; and urine drug tests at screening
- Female with no childbearing potential
- History or current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
- Relevant medical history or presence of systemic disease (gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, infectious disease), or significant skin disease
- History or presence of clinically significant electrocardiogram at screening
- Abnormal laboratory values at screening
About this study
Official title: A Phase I, Two-Panel, Open-Label, Randomized, 3-way Crossover Trial in Healthy Subjects to Determine the Relative Oral Bioavailability of TMC207 After Single Dose Administration of TMC207 100 mg as the Phase II Clinical Trial Tablet Formulation and as a Newly Developed Tablet Formulation, Under Fed and Fasted Conditions
The purpose of this study is to determine the relative oral bioavailability (the extent to which a medication or other substance becomes available to the body as compared with another form of medication or other substance) of TMC207 after single-dose oral administration of the Phase II clinical study tablet formulation, and a newly developed tablet formulations, under fed (with food) and fasted (without food) conditions.
Read the detailed description
This is a 2-panel (2 groups), open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), 3- way crossover (method used to switch participants from one treatment arm to another in a clinical study) study. The study consists of 3 phases including, the screening phase (less than or equal to 21 days before administration of study medication), treatment phase (84 days), and the follow-up phase (up to 30 to 35 days after the last blood sample in the last treatment session is collected). Approximately 24 healthy participants will be allocated to one of two panels: Panel A (participants will receive study medication under fed condition); and Panel B (participants will receive study medication under fasted condition). Participants in Panel A will be randomly assigned to 1 of 6 treatment sequences (Treatment sequences ABC, ACB, BAC, BCA, CBA, and CAB) to receive the following 3 formulations of TMC207 with food: Treatments A: the Phase II tablet formulation; Treatment B: newly developed tablet formulation with fine particle size distribution; and Treatment C: newly developed tablet formulation with coarse particle size distribution. Participants in Panel B will be randomly assigned to 1 of 6 treatment sequences (Treatment sequences DEF, DFE, EDF, EFD, FDE, and FED) to receive the following 3 formulations of TMC207 without food: Treatments D: the Phase II tablet formulation; Treatment E: newly developed tablet formulation with fine particle size distribution; and Treatment F: newly developed tablet formulation with coarse particle size distribution. Subsequent treatments will be separated by a period of 4 weeks. The total duration of the study for each participant will be approximately 20 weeks. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, electrocardiogram, physical examination, and alcohol urine medicine screen which will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- Treatment A, Treatment B, Treatment C, Treatment D, Treatment E
- Keywords
- Healthy, Bioavailability, Relative bioavailability, TMC207, Fed condition, Fasted condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
Participants will receive phase II clinical study tablet formulation of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.
Treatment BDrug
Participants will receive newly developed tablet formulation with fine particle size distribution of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.
Treatment CDrug
Participants will receive newly developed tablet formulation with coarse particle size distribution of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.
Treatment DDrug
Participants will receive phase II clinical study tablet formulation of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58.
Treatment EDrug
Participants will receive newly developed tablet formulation with fine particle size distribution of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58.
Treatment FDrug
Participants will receive newly developed tablet formulation with coarse particle size distribution of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58
| Study group | Role | What they receive |
|---|---|---|
| Panel A: Treatment Sequence ABC | Experimental | Participants will receive the 3 treatments (Treatment A,B and C) in sequence ABC with food and subsequent treatments will be separated by 4 weeks. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Panel A: Treatment Sequence ACB | Experimental | Participants will receive the 3 treatments (Treatment A,B and C) in sequence ACB with food and subsequent treatments will be separated by 4 weeks. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Panel A: Treatment Sequence BAC | Experimental | Participants will receive the 3 treatments (Treatment A,B and C) in sequence BAC with food and subsequent treatments will be separated by 4 weeks. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Panel A: Treatment Sequence BCA | Experimental | Participants will receive the 3 treatments (Treatment A,B and C) in sequence BCA with food and subsequent treatments will be separated by 4 weeks. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Panel A: Treatment Sequence CBA | Experimental | Participants will receive the 3 treatments (Treatment A,B and C) in sequence CBA with food and subsequent treatments will be separated by 4 weeks. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Panel A: Treatment Sequence CAB | Experimental | Participants will receive the 3 treatments (Treatment A,B and C) in sequence CAB with food and subsequent treatments will be separated by 4 weeks. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Panel B: Treatment Sequence DEF | Experimental | Participants will receive the 3 treatments (Treatment D,E and F) in sequence DEF with food and subsequent treatments will be separated by 4 weeks. Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F |
| Panel B: Treatment Sequence DFE | Experimental | Participants will receive the 3 treatments (Treatment D,E and F) in sequence DFE with food and subsequent treatments will be separated by 4 weeks.. Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F |
| Panel B: Treatment Sequence EDF | Experimental | Participants will receive the 3 treatments (Treatment D,E and F) in sequence EDF with food and subsequent treatments will be separated by 4 weeks. Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F |
| Panel B: Treatment Sequence EFD | Experimental | Participants will receive the 3 treatments (Treatment D,E and F) in sequence EFD with food and subsequent treatments will be separated by 4 weeks. Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F |
| Panel B: Treatment Sequence FDE | Experimental | Participants will receive the 3 treatments (Treatment D,E and F) in sequence FDE with food and subsequent treatments will be separated by 4 weeks. Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F |
| Panel B: Treatment Sequence FED | Experimental | Participants will receive the 3 treatments (Treatment D,E and F) in sequence FED with food and subsequent treatments will be separated by 4 weeks. Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Reach the Maximum Plasma Concentration of TMC207
Measured: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Maximum Plasma Concentration of TMC207
Measured: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Area Under Curve From Time of Administration up to 72 Hours Post Dosing of TMC207
Measured: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Secondary outcomes (8)
Time to Reach the Maximum Plasma Concentration of M2 Metabolite of TMC207
Measured: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Maximum Plasma Concentration of M2 Metabolite of TMC207
Measured: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Area Under Curve From Time of Administration up to 72 Hours Post Dosing of M2 Metabolite of TMC207
Measured: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Area Under Curve From Time of Administration up to the Last Time Point With a Measurable Concentration Post Dosing of M2 Metabolite of TMC207
Measured: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Area Under Curve Extrapolated to Infinity of M2 Metabolite of TMC207
Measured: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Elimination Rate Constant of a Sequential Elimination Phase of the Plasma Concentration-Time Curve of M2 Metabolite of TMC207
Measured: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Elimination Half-Life of M2 Metabolite of TMC207
Measured: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Number of Participants With Adverse Events
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT00946842
- Sponsor's protocol ID
- CR007504
- Other IDs
- TMC207-TIDP13-C111, TMC207-C111
- Status last verified
- Mar 2013
- First submitted
- 23 Jul 2009
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Two-Panel, Open-Label, Randomized, 3-way Crossover Trial in Healthy Subjects to Determine the Relative Oral Bioavailability of TMC207 After Single Dose Administration of TMC207 100 mg as the Phase II Clinical Trial Tablet Formulation and as a Newly Developed Tablet Formulation, Under Fed and Fasted Conditions
- ClinicalTrials.gov ID
- NCT00946842
- Acronym / sponsor ID
- CR007504
- Conditions
- Healthy
- Keywords
- Healthy, Bioavailability, Relative bioavailability, TMC207, Fed condition, Fasted condition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Tibotec BVBAIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Jul 2009 (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 determine the relative oral bioavailability (the extent to which a medication or other substance becomes available to the body as compared with another form of medication or other substance) of TMC207 after single-dose oral administration of the Phase II clinical study tablet formulation, and a newly developed tablet formulations, under fed (with food) and fasted (without food) conditions.
Detailed description
This is a 2-panel (2 groups), open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), 3- way crossover (method used to switch participants from one treatment arm to another in a clinical study) study. The study consists of 3 phases including, the screening phase (less than or equal to 21 days before administration of study medication), treatment phase (84 days), and the follow-up phase (up to 30 to 35 days after the last blood sample in the last treatment session is collected). Approximately 24 healthy participants will be allocated to one of two panels: Panel A (participants will receive study medication under fed condition); and Panel B (participants will receive study medication under fasted condition). Participants in Panel A will be randomly assigned to 1 of 6 treatment sequences (Treatment sequences ABC, ACB, BAC, BCA, CBA, and CAB) to receive the following 3 formulations of TMC207 with food: Treatments A: the Phase II tablet formulation; Treatment B: newly developed tablet formulation with fine particle size distribution; and Treatment C: newly developed tablet formulation with coarse particle size distribution. Participants in Panel B will be randomly assigned to 1 of 6 treatment sequences (Treatment sequences DEF, DFE, EDF, EFD, FDE, and FED) to receive the following 3 formulations of TMC207 without food: Treatments D: the Phase II tablet formulation; Treatment E: newly developed tablet formulation with fine particle size distribution; and Treatment F: newly developed tablet formulation with coarse particle size distribution. Subsequent treatments will be separated by a period of 4 weeks. The total duration of the study for each participant will be approximately 20 weeks. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, electrocardiogram, physical examination, and alcohol urine medicine screen which will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Panel A: Treatment Sequence ABC | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants will receive the 3 treatments (Treatment A,B and C) in sequence ABC with food and subsequent treatments will be separated by 4 weeks. |
| Panel A: Treatment Sequence ACB | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants will receive the 3 treatments (Treatment A,B and C) in sequence ACB with food and subsequent treatments will be separated by 4 weeks. |
| Panel A: Treatment Sequence BAC | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants will receive the 3 treatments (Treatment A,B and C) in sequence BAC with food and subsequent treatments will be separated by 4 weeks. |
| Panel A: Treatment Sequence BCA | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants will receive the 3 treatments (Treatment A,B and C) in sequence BCA with food and subsequent treatments will be separated by 4 weeks. |
| Panel A: Treatment Sequence CBA | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants will receive the 3 treatments (Treatment A,B and C) in sequence CBA with food and subsequent treatments will be separated by 4 weeks. |
| Panel A: Treatment Sequence CAB | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants will receive the 3 treatments (Treatment A,B and C) in sequence CAB with food and subsequent treatments will be separated by 4 weeks. |
| Panel B: Treatment Sequence DEF | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment FParticipants will receive the 3 treatments (Treatment D,E and F) in sequence DEF with food and subsequent treatments will be separated by 4 weeks. |
| Panel B: Treatment Sequence DFE | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment FParticipants will receive the 3 treatments (Treatment D,E and F) in sequence DFE with food and subsequent treatments will be separated by 4 weeks.. |
| Panel B: Treatment Sequence EDF | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment FParticipants will receive the 3 treatments (Treatment D,E and F) in sequence EDF with food and subsequent treatments will be separated by 4 weeks. |
| Panel B: Treatment Sequence EFD | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment FParticipants will receive the 3 treatments (Treatment D,E and F) in sequence EFD with food and subsequent treatments will be separated by 4 weeks. |
| Panel B: Treatment Sequence FDE | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment FParticipants will receive the 3 treatments (Treatment D,E and F) in sequence FDE with food and subsequent treatments will be separated by 4 weeks. |
| Panel B: Treatment Sequence FED | Experimental | Drug: Treatment D, Drug: Treatment E, Drug: Treatment FParticipants will receive the 3 treatments (Treatment D,E and F) in sequence FED with food and subsequent treatments will be separated by 4 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-smoker or smokers with no more than 10 cigarettes or 2 cigars or 2 pipes per day for at least 3 months prior selection
- Normal weight as defined by a body mass index (weight in kilograms divided by the square of height in meters) of 18 to 30 kg/m2, extremes included
- Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality
Key exclusion criteria (6 listed)
- Positive tests for Human Immunodeficiency Virus 1 (HIV type 1) or HIV 2; hepatitis A, hepatitis B, or hepatitis C infection; and urine drug tests at screening
- Female with no childbearing potential
- History or current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
- Relevant medical history or presence of systemic disease (gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, infectious disease), or significant skin disease
- History or presence of clinically significant electrocardiogram 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 |
|---|---|---|
| Treatment AParticipants will receive phase II clinical study tablet formulation of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58. | Drug | Panel A: Treatment Sequence ABC, Panel A: Treatment Sequence ACB, Panel A: Treatment Sequence BAC, Panel A: Treatment Sequence BCA, Panel A: Treatment Sequence CAB, Panel A: Treatment Sequence CBA |
| Treatment BParticipants will receive newly developed tablet formulation with fine particle size distribution of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58. | Drug | Panel A: Treatment Sequence ABC, Panel A: Treatment Sequence ACB, Panel A: Treatment Sequence BAC, Panel A: Treatment Sequence BCA, Panel A: Treatment Sequence CAB, Panel A: Treatment Sequence CBA |
| Treatment CParticipants will receive newly developed tablet formulation with coarse particle size distribution of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58. | Drug | Panel A: Treatment Sequence ABC, Panel A: Treatment Sequence ACB, Panel A: Treatment Sequence BAC, Panel A: Treatment Sequence BCA, Panel A: Treatment Sequence CAB, Panel A: Treatment Sequence CBA |
| Treatment DParticipants will receive phase II clinical study tablet formulation of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58. | Drug | Panel B: Treatment Sequence DEF, Panel B: Treatment Sequence DFE, Panel B: Treatment Sequence EDF, Panel B: Treatment Sequence EFD, Panel B: Treatment Sequence FDE, Panel B: Treatment Sequence FED |
| Treatment EParticipants will receive newly developed tablet formulation with fine particle size distribution of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58. | Drug | Panel B: Treatment Sequence DEF, Panel B: Treatment Sequence DFE, Panel B: Treatment Sequence EDF, Panel B: Treatment Sequence EFD, Panel B: Treatment Sequence FDE, Panel B: Treatment Sequence FED |
| Treatment FParticipants will receive newly developed tablet formulation with coarse particle size distribution of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58 | Drug | Panel B: Treatment Sequence DEF, Panel B: Treatment Sequence DFE, Panel B: Treatment Sequence EDF, Panel B: Treatment Sequence EFD, Panel B: Treatment Sequence FDE, Panel B: Treatment Sequence FED |
Primary outcome
Time to Reach the Maximum Plasma Concentration of TMC207
Time frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Maximum Plasma Concentration of TMC207
Time frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Area Under Curve From Time of Administration up to 72 Hours Post Dosing of TMC207
Time frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
8 secondary outcomes
Time to Reach the Maximum Plasma Concentration of M2 Metabolite of TMC207
Time frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Maximum Plasma Concentration of M2 Metabolite of TMC207
Time frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Area Under Curve From Time of Administration up to 72 Hours Post Dosing of M2 Metabolite of TMC207
Time frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Area Under Curve From Time of Administration up to the Last Time Point With a Measurable Concentration Post Dosing of M2 Metabolite of TMC207
Time frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Area Under Curve Extrapolated to Infinity of M2 Metabolite of TMC207
Time frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Elimination Rate Constant of a Sequential Elimination Phase of the Plasma Concentration-Time Curve of M2 Metabolite of TMC207
Time frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Elimination Half-Life of M2 Metabolite of TMC207
Time frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration
Number of Participants With Adverse Events
Time frame: Up to 20 weeks
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 19 Mar 2013.
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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 Treatment A, Treatment B and Treatment C in people with Healthy, 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 3 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 19 Mar 2013. 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. 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?
Time to Reach the Maximum Plasma Concentration of TMC207 (time frame: 0 hour predose to 672 hours postdose, after each of the 3 single-dose administration). The study lists 3 primary outcomes in all. 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 19 Mar 2013.