HealthyPhase 1NCT02251158
Bioavailability of Tipranavir/Ritonavir Paediatric Solution Compared to Tipranavir/Ritonavir Capsules in Healthy Female and Male Subjects
A Phase 1 study testing Tipranavir oral solution, Tipranavir capsules and Ritonavir oral solution in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to determine the relative bioavailability of 500/200 mg of tipranavir/ritonavir (TPV/r) oral solution compared to 500/200 mg of TPV/r capsules following oral administration and to investigate the relative bioavailability of 500/200 mg of TPV/r oral solution with food versus without food. 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?
- Tipranavir oral solution, Tipranavir capsules and Ritonavir oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Dec 2003
- 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 males and females according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
- No finding deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥ 18 and Age ≤ 55 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Who cannot join
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 26Show fewer
- Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial (e.g. drugs which contain polyethylene glycol or vitamin E)
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes/day or 3 cigars/day or 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Veins unsuited for iv puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- History of any bleeding disorder or acute blood coagulation defect of vitamin K deficiency caused by anticoagulation therapy or malabsorption
- Vitamin E supplement intake
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
About this study
Official title: Relative Bioavailability of 500/200 mg of Tipranavir/Ritonavir Paediatric Solution Compared to 500/200 mg of Tipranavir/Ritonavir Capsules Following Oral Administration and Bioavailability of 500/200 mg Tipranavir/Ritonavir Paediatric Solution Under the Influence of Food in Healthy Female and Male Subjects. An Open-label, Randomised, Single-dose, Three-way Crossover Trial.
Study to determine the relative bioavailability of 500/200 mg of tipranavir/ritonavir (TPV/r) oral solution compared to 500/200 mg of TPV/r capsules following oral administration and to investigate the relative bioavailability of 500/200 mg of TPV/r oral solution with food versus without food.
- Conditions
- Healthy
- Being tested
- Tipranavir oral solution, Tipranavir capsules, Ritonavir oral solution, Ritonavir soft gel capsules, High fat breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tipranavir oral solutionDrug
Tipranavir capsulesDrug
Ritonavir oral solutionDrug
Ritonavir soft gel capsulesDrug
High fat breakfastOther
| Study group | Role | What they receive |
|---|---|---|
| TPV/r with food | Experimental | Tipranavir/Ritonavir paediatric/oral solution Receives: Drug: Tipranavir oral solution; Drug: Ritonavir oral solution; Other: High fat breakfast |
| TPV/r | Experimental | Tipranavir/Ritonavir paediatric/oral solution Receives: Drug: Tipranavir oral solution; Drug: Ritonavir oral solution |
| TPV/r capsules | Active comparator | Not described Receives: Drug: Tipranavir capsules; Drug: Ritonavir soft gel capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (area under the concentration time curve of tipranavir in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 72 hours after drug administration
Cmax (maximum concentration of tipranavir in plasma)
Measured: up to 72 hours after drug administration
Secondary outcomes (7)
AUC0-tz (area under the concentration-time curve of tipranavir in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 72 hours after drug administration
tmax (time from dosing to the maximum concentration of tipranavir in plasma)
Measured: up to 72 hours after drug administration
t1/2 (terminal half-life of tipranavir in plasma)
Measured: up to 72 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Measured: up to 72 hours after drug administration
CLpo/F (apparent clearance of tipranavir in the plasma after extravascular administration)
Measured: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 72 hours after drug administration
Number of subjects with adverse events
Measured: up to day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startOct 2003
- Primary completionDec 2003
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.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251158
- Sponsor's protocol ID
- 1182.45
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2014
- Last updated
- 29 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of 500/200 mg of Tipranavir/Ritonavir Paediatric Solution Compared to 500/200 mg of Tipranavir/Ritonavir Capsules Following Oral Administration and Bioavailability of 500/200 mg Tipranavir/Ritonavir Paediatric Solution Under the Influence of Food in Healthy Female and Male Subjects. An Open-label, Randomised, Single-dose, Three-way Crossover Trial.
- ClinicalTrials.gov ID
- NCT02251158
- Acronym / sponsor ID
- 1182.45
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Dec 2003 (actual)
- First posted
- 29 Sep 2014 (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.
Study to determine the relative bioavailability of 500/200 mg of tipranavir/ritonavir (TPV/r) oral solution compared to 500/200 mg of TPV/r capsules following oral administration and to investigate the relative bioavailability of 500/200 mg of TPV/r oral solution with food versus without food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TPV/r with food | Experimental | Drug: Tipranavir oral solution, Drug: Ritonavir oral solution, Other: High fat breakfastTipranavir/Ritonavir paediatric/oral solution |
| TPV/r | Experimental | Drug: Tipranavir oral solution, Drug: Ritonavir oral solutionTipranavir/Ritonavir paediatric/oral solution |
| TPV/r capsules | Active comparator | Drug: Tipranavir capsules, Drug: Ritonavir soft gel capsules |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy males and females according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
- Age ≥ 18 and Age ≤ 55 years
- BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Key exclusion criteria (26 listed)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
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 |
|---|---|---|
| Tipranavir oral solution | Drug | TPV/r, TPV/r with food |
| Tipranavir capsules | Drug | TPV/r capsules |
| Ritonavir oral solution | Drug | TPV/r, TPV/r with food |
| Ritonavir soft gel capsules | Drug | TPV/r capsules |
| High fat breakfast | Other | TPV/r with food |
Primary outcome
AUC0-∞ (area under the concentration time curve of tipranavir in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 hours after drug administration
Cmax (maximum concentration of tipranavir in plasma)
Time frame: up to 72 hours after drug administration
7 secondary outcomes
AUC0-tz (area under the concentration-time curve of tipranavir in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 72 hours after drug administration
tmax (time from dosing to the maximum concentration of tipranavir in plasma)
Time frame: up to 72 hours after drug administration
t1/2 (terminal half-life of tipranavir in plasma)
Time frame: up to 72 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 72 hours after drug administration
CLpo/F (apparent clearance of tipranavir in the plasma after extravascular administration)
Time frame: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours after drug administration
Number of subjects with adverse events
Time frame: up to day 18
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 29 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tipranavir oral solution, Tipranavir capsules and Ritonavir oral solution in people with Healthy, run by Boehringer Ingelheim.
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 7 inclusion and 26 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 29 Sep 2014. 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?
AUC0-∞ (area under the concentration time curve of tipranavir in plasma over the time interval from 0 extrapolated to infinity) (time frame: up to 72 hours after drug administration). The study lists 2 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 29 Sep 2014.