HealthyPhase 1NCT02227017
Relative Bioavailability of Tipranavir (TPV)/Ritonavir (RTV) at Steady State Administered as Oral Solutions vs. Capsules in the Fed and Fasted State in Healthy Volunteers
A Phase 1 study testing TPV capsule, TPV solution and RTV capsule in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to establish the relative bioavailability of the TPV oral solution formulation (500 mg coadministered with RTV oral solution 200 mg) to the TPV capsule formulation (500 mg coadministered with RTV capsules 200 mg), with both treatments at steady-state under fasted and fed conditions in healthy male and female… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TPV capsule, TPV solution and RTV capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Apr 2006
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects 18 to 65 years of age inclusive
- A Body Mass Index (BMI): ≥18.5 and ≤35 kg/m2
- Signed informed consent prior to performance of any study procedures
- Ability to swallow multiple large capsules without difficulty
- Screening laboratory values within the normal range. Inclusion of any subject with an abnormal laboratory value was subject to approval by the BI trial clinical monitor
- Acceptable medical history, physical examination, and 12-lead ECG at screening
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- Willingness to abstain from the following starting 5 days prior to administration of any study medication and up until the end of the study:
- Grapefruit or grapefruit juice, red wine, Seville oranges, St. John's Wort and Milk Thistle
- Willingness to abstain from the following starting 3 days prior to administration of any study medication up to the end of the study:
- Garlic supplements and methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.), apples and apple juice
- Willingness to abstain from over-the-counter herbal medications for the duration of the study
- Are non-smokers
- Willingness to abstain from vigorous physical exercise during intensive pharmacokinetic days 10, 11, 14, 15
- Reasonable probability for completion of the study
Who cannot join
- Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study
- Female subjects of reproductive potential who:
- Have a positive pregnancy test
- Have not been using a barrier method of contraception for at least 3 months prior to participation in the study
- Are not willing to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and 60 days after completion/termination of the trial
- Are breast-feeding
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- Use any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to Day 0 and for the duration of the study. Due to long half-life, subjects using Depo-Provera® within 6 months prior to Day 1 are excluded from participation in this study
- Use of hormone replacement therapy within 1 month prior to Day 0 and anytime during the study
- Use of any medication listed in Protocol within 30 days prior to Day 0 of this study
- Administration of antibiotics within 15 days prior to Day 0 and anytime during the study
- History of acute illness within 60 days prior to Day 0
- Subjects will be excluded for acute illnesses that occurred more than 60 days prior to Day 0 if, in the opinion of the investigator, the subject did not qualify as a healthy volunteer
- Serological evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Serological evidence of exposure to HIV
- Alcohol or substance abuse within 1 year prior to screening or during the study
- Blood or plasma donations within 30 days prior to Day 0 or during the study
- Subjects with a history of any illness or allergy that, in the opinion of the investigator, might have confounded the results of the study or pose additional risk in administering TPV, or RTV to the subject
- Subjects who have taken (within 7 days prior to Day 0) any over-the-counter or prescription medication that, in the opinion of the investigator in consultation with the sponsor's clinical monitor, might have interfered with absorption, distribution, or metabolism of the study medications
- Known hypersensitivity to sulphonamide class of drugs
- Known hypersensitivity to TPV, RTV, or antiretroviral drugs (marketed or experimental use as part of clinical research studies)
- Known elevated liver enzymes in past trials with any compound
- Known allergy to nuts or nut products (A spoonful of peanut or hazelnut butter was taken immediately before administration of TPV or RTV oral solution, to help mask the taste of the solutions)
- Inability to adhere to the protocol
- Inability to consume a standard high-fat meal
- Cautions or warnings in the package insert which, in the opinion of the investigator, constituted grounds for subject exclusion
About this study
Official title: An Open-label, Single-site, One-sequence Cross-over Study to Assess the Relative Bioavailability of TPV/r 500 mg/200 mg at Steady State When TPV and RTV Are Administered as Oral Solutions vs. Capsules in the Fed and Fasted State.
Study to establish the relative bioavailability of the TPV oral solution formulation (500 mg coadministered with RTV oral solution 200 mg) to the TPV capsule formulation (500 mg coadministered with RTV capsules 200 mg), with both treatments at steady-state under fasted and fed conditions in healthy male and female volunteers.
- Conditions
- Healthy
- Being tested
- TPV capsule, TPV solution, RTV capsule, RTV solution, standard meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPV capsuleDrug
TPV solutionDrug
RTV capsuleDrug
RTV solutionDrug
standard mealOther
| Study group | Role | What they receive |
|---|---|---|
| TPV/RTV capsules fed | Experimental | Not described Receives: Drug: TPV capsule; Drug: RTV capsule; Other: standard meal |
| TPV/RTV capsules fasted | Experimental | Not described Receives: Drug: TPV capsule; Drug: RTV capsule |
| TPV/RTV solutions fed | Active comparator | Not described Receives: Drug: TPV solution; Drug: RTV solution; Other: standard meal |
| TPV/RTV solutions fasted | Active comparator | Not described Receives: Drug: TPV solution; Drug: RTV solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of TPV from time zero to 12 hours at steady state (AUC0-12)
Measured: up to 12 hours after drug administration
Secondary outcomes (10)
Area under the concentration-time curve of RTV from time zero to 12 hours at steady state (AUC0-12)
Measured: up to 12 hours after drug administration
Maximum measured concentration of the analyte in plasma at steady state (Cmax)
Measured: up to 12 hours after drug administration
Drug concentration in plasma after 12 hours at steady state (Cp12h)
Drug concentration in plasma at last measurement (Cplast) if Cp12h is below limit of quantification (BLQ)
Measured: up to 12 hours after drug administration
Apparent clearance of the analyte in plasma at steady state following extravascular administration (CL/F)
Measured: up to 12 hours after drug administration
Volume of distribution at steady state (Vd)
Measured: up to 12 hours after drug administration
Terminal half life at steady state (t1/2)
Measured: up to 12 hours after drug administration
Number of subjects with adverse events
Measured: up to day 16
Number of subjects with clinically significant findings in vital signs
blood pressure, pulse rate
Measured: up to day 16
Number of subjects with clinically significant findings in ECG
Measured: up to day 16
Number of subjects with clinically significant findings in laboratory tests
Measured: up to day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startFeb 2006
- Primary completionApr 2006
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT02227017
- Sponsor's protocol ID
- 1182.100
- Status last verified
- Aug 2014
- First submitted
- 26 Aug 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-site, One-sequence Cross-over Study to Assess the Relative Bioavailability of TPV/r 500 mg/200 mg at Steady State When TPV and RTV Are Administered as Oral Solutions vs. Capsules in the Fed and Fasted State.
- ClinicalTrials.gov ID
- NCT02227017
- Acronym / sponsor ID
- 1182.100
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Apr 2006 (actual)
- First posted
- 27 Aug 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 establish the relative bioavailability of the TPV oral solution formulation (500 mg coadministered with RTV oral solution 200 mg) to the TPV capsule formulation (500 mg coadministered with RTV capsules 200 mg), with both treatments at steady-state under fasted and fed conditions in healthy male and female volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TPV/RTV capsules fed | Experimental | Drug: TPV capsule, Drug: RTV capsule, Other: standard meal |
| TPV/RTV capsules fasted | Experimental | Drug: TPV capsule, Drug: RTV capsule |
| TPV/RTV solutions fed | Active comparator | Drug: TPV solution, Drug: RTV solution, Other: standard meal |
| TPV/RTV solutions fasted | Active comparator | Drug: TPV solution, Drug: RTV solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male and female subjects 18 to 65 years of age inclusive
- A Body Mass Index (BMI): ≥18.5 and ≤35 kg/m2
- Signed informed consent prior to performance of any study procedures
- Ability to swallow multiple large capsules without difficulty
- Screening laboratory values within the normal range. Inclusion of any subject with an abnormal laboratory value was subject to approval by the BI trial clinical monitor
Key exclusion criteria (25 listed)
- Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study
- Female subjects of reproductive potential who:
- Use of any medication listed in Protocol within 30 days prior to Day 0 of this study
- Administration of antibiotics within 15 days prior to Day 0 and anytime during the study
- History of acute illness within 60 days prior to Day 0
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 |
|---|---|---|
| TPV capsule | Drug | TPV/RTV capsules fasted, TPV/RTV capsules fed |
| TPV solution | Drug | TPV/RTV solutions fasted, TPV/RTV solutions fed |
| RTV capsule | Drug | TPV/RTV capsules fasted, TPV/RTV capsules fed |
| RTV solution | Drug | TPV/RTV solutions fasted, TPV/RTV solutions fed |
| standard meal | Other | TPV/RTV capsules fed, TPV/RTV solutions fed |
Primary outcome
Area under the concentration-time curve of TPV from time zero to 12 hours at steady state (AUC0-12)
Time frame: up to 12 hours after drug administration
10 secondary outcomes
Area under the concentration-time curve of RTV from time zero to 12 hours at steady state (AUC0-12)
Time frame: up to 12 hours after drug administration
Maximum measured concentration of the analyte in plasma at steady state (Cmax)
Time frame: up to 12 hours after drug administration
Drug concentration in plasma after 12 hours at steady state (Cp12h)
Time frame: up to 12 hours after drug administration
Apparent clearance of the analyte in plasma at steady state following extravascular administration (CL/F)
Time frame: up to 12 hours after drug administration
Volume of distribution at steady state (Vd)
Time frame: up to 12 hours after drug administration
Terminal half life at steady state (t1/2)
Time frame: up to 12 hours after drug administration
Number of subjects with adverse events
Time frame: up to day 16
Number of subjects with clinically significant findings in vital signs
Time frame: up to day 16
Number of subjects with clinically significant findings in ECG
Time frame: up to day 16
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to day 16
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 27 Aug 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 TPV capsule, TPV solution and RTV capsule 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 14 inclusion and 25 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 27 Aug 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?
Area under the concentration-time curve of TPV from time zero to 12 hours at steady state (AUC0-12) (time frame: up to 12 hours after drug administration). 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 27 Aug 2014.