PharmacokineticsPhase 1NCT00752310
TMC114-TiDP29-C169: Bioavailability and Pharmacokinetics Trial Comparing Darunavir Pediatric Suspension Formulation to Current Darunavir Tablet
A Phase 1 study testing Darunavir in people with Pharmacokinetics, run by Tibotec Pharmaceuticals, Ireland.
Trial summary
The purpose of this study is to evaluate in healthy volunteers how much and how fast the new suspension compared to the commercial darunavir tablet, given in combination with low-dose ritonavir, are absorbed into the body (called the relative oral bioavailability). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Darunavir
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Aug 2008
- 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
- Normal weight as defined by 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
- 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 (ECG), vital signs, and the results of blood biochemistry, blood coagulation, and hematology tests and a urinalysis carried out at screening.
Who cannot join
- No positive HIV 1 or HIV 2 test at screening
- no history of significant skin disease such as, but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, or urticaria
- no history of allergy to drugs such as, but not limited to, sulphonamides and penicillins
- no previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication administered in this trial
- no female subject of childbearing potential without use of effective nonhormonal birth control methods, or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
- no positive pregnancy test or breast feeding at screening
About this study
Official title: A Phase I, Open-label, Randomized, Crossover Trial in Healthy Subjects Receiving DRV Combined With RTV Low Dose to Compare the Oral Bioavailability of DRV Suspension to That of DRV 300 mg Tablet Under Fasted and Fed Conditions, and to Assess Multiple Dose Pharmacokinetics of the DRV Suspension
The purpose of this study is to evaluate in healthy volunteers how much and how fast the new suspension compared to the commercial darunavir tablet, given in combination with low-dose ritonavir, are absorbed into the body (called the relative oral bioavailability).
Read the detailed description
The objectives of this trial are in Part 1 to compare the rate and extent of absorption of a single oral dose of 600 mg darunavir (DRV) administered as the suspension formulation F051 (under fed and fasted conditions) to that of the commercial tablet formulation F016 (under fed conditions), in the presence of low-dose ritonavir in healthy volunteers; and to compare the rate and extent of absorption of a single oral dose of 600 mg DRV administered as the suspension formulation F051 under fed conditions to that under fasted conditions, in the presence of low-dose ritonavir in healthy volunteers. In Part 2 we want to assess multiple dose pharmacokinetics of DRV administered as the suspension formulation F051 (under fed or fasted conditions, based on the results of Part 1), in the presence of low-dose ritonavir in healthy volunteers. The short-term safety and tolerability of DRV will be evaluated following administration of 3 single oral doses of 600 mg (formulated as suspension and as tablet) and following administration of multiple oral doses (formulated as suspension), all in presence of low-dose ritonavir in healthy volunteers Part 1: during 3 sessions volunteers will orally receive 3 single doses of 600 mg darunavir (DRV): 2 tablets of 300 mg and 6 ml of suspension under fed conditions and 6 mL of suspension (100 mg/mL) under fasted conditions on Day 3. Part 2: subjects will receive DRV suspension, twice daily from Day 1 to 6, with an additional morning dose on Day 7. In Part I rtv 100 mg will be coadministered twice daily from Day 1 to Day 5 and in Part 2 from Day 1 to Day 9.
- Conditions
- Pharmacokinetics
- Being tested
- Darunavir
- Keywords
- TMC114-TiDP29-C169, TMC114-C169, Darunavir (suspension formulation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarunavirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: plasma concentrations of DRV and RTV. Time frame day 3: predose and up to 12h, then at 24, 48, 72h. Part 2: plasma concentrations of DRV and RTV. Time frame: predose day 1 and day 5-6; day 7 predose and up to 12h, then at 24, 48, 72h.
Secondary outcomes (1)
Short term safety and tolerability of DRV, formulated as suspension or as tablet, in the presence of low-dose RTV.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2008
- Study completionAug 2008
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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tibotec Pharmaceuticals Limited Clinical Trial, Study director, Tibotec Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752310
- Sponsor's protocol ID
- CR012565
- Status last verified
- Apr 2010
- First submitted
- 11 Sep 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 Subjects Receiving DRV Combined With RTV Low Dose to Compare the Oral Bioavailability of DRV Suspension to That of DRV 300 mg Tablet Under Fasted and Fed Conditions, and to Assess Multiple Dose Pharmacokinetics of the DRV Suspension
- ClinicalTrials.gov ID
- NCT00752310
- Acronym / sponsor ID
- CR012565
- Conditions
- Pharmacokinetics
- Keywords
- TMC114-TiDP29-C169, TMC114-C169, Darunavir (suspension formulation)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 15 Sep 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 in healthy volunteers how much and how fast the new suspension compared to the commercial darunavir tablet, given in combination with low-dose ritonavir, are absorbed into the body (called the relative oral bioavailability).
Detailed description
The objectives of this trial are in Part 1 to compare the rate and extent of absorption of a single oral dose of 600 mg darunavir (DRV) administered as the suspension formulation F051 (under fed and fasted conditions) to that of the commercial tablet formulation F016 (under fed conditions), in the presence of low-dose ritonavir in healthy volunteers; and to compare the rate and extent of absorption of a single oral dose of 600 mg DRV administered as the suspension formulation F051 under fed conditions to that under fasted conditions, in the presence of low-dose ritonavir in healthy volunteers. In Part 2 we want to assess multiple dose pharmacokinetics of DRV administered as the suspension formulation F051 (under fed or fasted conditions, based on the results of Part 1), in the presence of low-dose ritonavir in healthy volunteers. The short-term safety and tolerability of DRV will be evaluated following administration of 3 single oral doses of 600 mg (formulated as suspension and as tablet) and following administration of multiple oral doses (formulated as suspension), all in presence of low-dose ritonavir in healthy volunteers Part 1: during 3 sessions volunteers will orally receive 3 single doses of 600 mg darunavir (DRV): 2 tablets of 300 mg and 6 ml of suspension under fed conditions and 6 mL of suspension (100 mg/mL) under fasted conditions on Day 3. Part 2: subjects will receive DRV suspension, twice daily from Day 1 to 6, with an additional morning dose on Day 7. In Part I rtv 100 mg will be coadministered twice daily from Day 1 to Day 5 and in Part 2 from Day 1 to Day 9.
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 (3 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
- Normal weight as defined by 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
- 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 (ECG), vital signs, and the results of blood biochemistry, blood coagulation, and hematology tests and a urinalysis carried out at screening.
Key exclusion criteria (6 listed)
- No positive HIV 1 or HIV 2 test at screening
- no history of significant skin disease such as, but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, or urticaria
- no history of allergy to drugs such as, but not limited to, sulphonamides and penicillins
- no previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication administered in this trial
- no female subject of childbearing potential without use of effective nonhormonal birth control methods, or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
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 |
|---|---|---|
| Darunavir | Drug | – |
Primary outcome
Part 1: plasma concentrations of DRV and RTV. Time frame day 3: predose and up to 12h, then at 24, 48, 72h. Part 2: plasma concentrations of DRV and RTV. Time frame: predose day 1 and day 5-6; day 7 predose and up to 12h, then at 24, 48, 72h.
1 secondary outcome
Short term safety and tolerability of DRV, formulated as suspension or as tablet, in the presence of low-dose RTV.
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.
- Bioavailability and Pharmacokinetics Trial Comparing Darunavir Pediatric Suspension Formulation to Current Darunavir TabletLink 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 Limited Clinical Trial study director
Tibotec Pharmaceutical Limited
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Darunavir in people with Pharmacokinetics, 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 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 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?
Part 1: plasma concentrations of DRV and RTV. Time frame day 3: predose and up to 12h, then at 24, 48, 72h. Part 2: plasma concentrations of DRV and RTV. Time frame: predose day 1 and day 5-6; day 7 predose and up to 12h, then at 24, 48, 72h.. 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.