PharmacokineticsPhase 1NCT00812292
TMC278-TiDP38-C145: A Bioavailability Study in Healthy Adult Volunteers to Evaluate 3 Pediatric Formulations of TMC278 (a Solution, a Suspension, and Granules) Compared to an Adult Tablet Formulation
A Phase 1 study testing TMC278 in people with Pharmacokinetics and Bioavailability, run by Tibotec Pharmaceuticals, Ireland.
Trial summary
The purpose of this study is to evaluate how much and how fast a single, oral, daily 25 mg dose of TMC278 is absorbed into the body when administered as a solution, suspension, granules, or a tablet. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Bioavailability, HIV-1
- What is being tested?
- TMC278
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 2009
- 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-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection
- A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
- Informed Consent Form signed voluntarily before the first trial-related activity
- Able to comply with protocol requirements
- Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram, vital signs, and the results of blood biochemistry and hematology tests and a urinalysis carried out at screening.
Who cannot join
- A positive HIV-1 or -2 test at trial screening
- Female, except if postmenopausal since more than two years, or post-hysterectomy or post-tubal ligation (without reversal operation)
- One or more risk factors for QTc prolongation
- Currently active gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease
About this study
Official title: A Phase I, Open-label, Randomized, Crossover Trial in Healthy Adults to Compare the Oral Bioavailability of TMC278 From Three Concept Pediatric Formulations (Solution, Suspension, Granules) With That From the Adult Phase III Tablet Formulation.
The purpose of this study is to evaluate how much and how fast a single, oral, daily 25 mg dose of TMC278 is absorbed into the body when administered as a solution, suspension, granules, or a tablet. In addition, the effect of each formulation of TMC278 will be evaluated in patients in the fasted and fed states and the palatability (how the drug tastes) of each formulation will be assessed. Finally, the safety and tolerability of each formulation of TMC278 will be assessed throughout the study.
Read the detailed description
This is an open-label (both investigator and volunteer knows the name of the assigned study medication), randomized (study medication will be assigned by chance) cross-over study in healthy adults to compare the rate and the extent of absorption of TMC278 when administered as a single 25 mg dose of the 3 concept pediatric formulations (solution [10 mg/mL], suspension [5 mg/mL], granules [2.5 mg/g]), under fed and fasted conditions, to that when administered as the 25 mg TMC278 Phase III tablet formulation, under fed conditions, in healthy adults and to assess the effect of food on the bioavailability of TMC278 after a single 25 mg dose of the concept pediatric TMC278 formulations in healthy adults. The palatability of the 3 concept formulations will be assessed in a fasted state by use of a questionnaire and a visual analog scale. The short-term safety and tolerability of TMC278 following administration of 3 single oral doses of 25 mg, formulated as one of the concept pediatric formulations (under fed and fasted conditions) and as the Phase III tablet (under fed conditions), in healthy adults will be evaluated. TMC278 25 mg formulated as a solution, suspension, granules, or tablet will be administered orally (by mouth). Each volunteer will receive on the first day of one treatment session one TMC278 25 mg tablet. On the first day of the other sessions they receive a single dose of TMC278 25 mg formulated as a the solution, a suspension or granules.
- Conditions
- Pharmacokinetics, Bioavailability, HIV-1
- Being tested
- TMC278
- Keywords
- TMC278, TMC278-C145, TMC278-TiDP38-C145, concept pediatric formulations of TMC278, HIV Infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC278Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
For each treatment session, full pharmacokinetic profiles will be measured up to 168 hours post-dosing
Secondary outcomes (1)
Safety and tolerability will be monitored throughout the trial. Palatability of the 3 concept formulations will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tibotec Pharmaceuticals Clinical Trial, Study director, Tibotec Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812292
- Sponsor's protocol ID
- CR012586
- Status last verified
- Apr 2010
- First submitted
- 18 Dec 2008
- Last updated
- 9 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Randomized, Crossover Trial in Healthy Adults to Compare the Oral Bioavailability of TMC278 From Three Concept Pediatric Formulations (Solution, Suspension, Granules) With That From the Adult Phase III Tablet Formulation.
- ClinicalTrials.gov ID
- NCT00812292
- Acronym / sponsor ID
- CR012586
- Conditions
- Pharmacokinetics, Bioavailability, HIV-1
- Keywords
- TMC278, TMC278-C145, TMC278-TiDP38-C145, concept pediatric formulations of TMC278, HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Dec 2008 (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 how much and how fast a single, oral, daily 25 mg dose of TMC278 is absorbed into the body when administered as a solution, suspension, granules, or a tablet. In addition, the effect of each formulation of TMC278 will be evaluated in patients in the fasted and fed states and the palatability (how the drug tastes) of each formulation will be assessed. Finally, the safety and tolerability of each formulation of TMC278 will be assessed throughout the study.
Detailed description
This is an open-label (both investigator and volunteer knows the name of the assigned study medication), randomized (study medication will be assigned by chance) cross-over study in healthy adults to compare the rate and the extent of absorption of TMC278 when administered as a single 25 mg dose of the 3 concept pediatric formulations (solution [10 mg/mL], suspension [5 mg/mL], granules [2.5 mg/g]), under fed and fasted conditions, to that when administered as the 25 mg TMC278 Phase III tablet formulation, under fed conditions, in healthy adults and to assess the effect of food on the bioavailability of TMC278 after a single 25 mg dose of the concept pediatric TMC278 formulations in healthy adults. The palatability of the 3 concept formulations will be assessed in a fasted state by use of a questionnaire and a visual analog scale. The short-term safety and tolerability of TMC278 following administration of 3 single oral doses of 25 mg, formulated as one of the concept pediatric formulations (under fed and fasted conditions) and as the Phase III tablet (under fed conditions), in healthy adults will be evaluated. TMC278 25 mg formulated as a solution, suspension, granules, or tablet will be administered orally (by mouth). Each volunteer will receive on the first day of one treatment session one TMC278 25 mg tablet. On the first day of the other sessions they receive a single dose of TMC278 25 mg formulated as a the solution, a suspension or granules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection
- A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
- Informed Consent Form signed voluntarily before the first trial-related activity
- Able to comply with protocol requirements
- Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram, vital signs, and the results of blood biochemistry and hematology tests and a urinalysis carried out at screening.
Key exclusion criteria (4 listed)
- A positive HIV-1 or -2 test at trial screening
- Female, except if postmenopausal since more than two years, or post-hysterectomy or post-tubal ligation (without reversal operation)
- One or more risk factors for QTc prolongation
- Currently active gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease
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 |
|---|---|---|
| TMC278 | Drug | – |
Primary outcome
For each treatment session, full pharmacokinetic profiles will be measured up to 168 hours post-dosing
1 secondary outcome
Safety and tolerability will be monitored throughout the trial. Palatability of the 3 concept formulations will be assessed.
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 9 Jun 2011.
- Phase I, open-label, randomized, crossover trial in healthy adults to compare the bioavailability of 3 concept pediatric formulations of TMC278 to the adult 25 mg Phase III tablet formulation, and to assess the food effect for each concept formulation.Link provided by the sponsor.
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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 Pharmaceuticals Clinical Trial study director
Tibotec Pharmaceutical Limited
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TMC278 in people with Pharmacokinetics and Bioavailability, run by Tibotec Pharmaceuticals, Ireland.
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 5 inclusion and 4 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 9 Jun 2011. 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?
For each treatment session, full pharmacokinetic profiles will be measured up to 168 hours post-dosing. 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 9 Jun 2011.