HealthyPhase 1NCT02243553
Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy Volunteers
A Phase 1 study testing Tipranavir capsule, Tipranavir solution and Ritonavir capsule in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Primary: To quantify the influence of single-dose and steady-state tipranavir/ritonavir 500/200 mg on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp) biomarkers, as a means of predicting drug interactions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tipranavir capsule, Tipranavir solution and Ritonavir capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jul 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- Healthy subjects aged between 18 years and 45 years inclusive
- Weighing at least 50 kg
- Volunteers must be hospitalized on Days 1-4, 7-9, and 17-20 for pharmacokinetic assessments for each biomarker and TPV/r (Days 7-9 and 17-20)
- Volunteers must be willing to complete all study-related activities
- Each volunteer must have a valid social security number
- Each volunteer must have acceptable medical history, physical examination and laboratory test
Who cannot join
- History or presence of allergy to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- History or diagnosis of any significant medical conditions: Including but not limited to gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, psychiatric, neurological, oncological or hormonal disorders
- Known elevated liver enzymes in past clinical trials with any compound (experimental or marketed)
- Clinically relevant laboratory abnormalities (e.g. Hgb<11g/dL, Hct<30g/dL, total cholesterol >240mg/dL, triglycerides >500mg/dL, fasting glucose >130mg/dL, liver function tests >2.5x upper limit of normal, baseline international normalized ratio >1.2)
- History of evidence of clinically significant hepatic, cardiac, pulmonary, endocrine, immunological, gastrointestinal, hematological, vascular or collagen disease
Show all 25Show fewer
- History of alcohol abuse or use of any illicit drugs
- Unable to abstain from more than one beer or alcohol equivalent per day for the duration of the study
- Use of tobacco products and/or history of smoking within the past 2 months
- Pregnant or breast feeding
- Sexually active women of childbearing age who do not use an acceptable barrier method of birth control
- Hypersensitivity to caffeine, warfarin, vitamin K, omeprazole, dextromethorphan, midazolam, tipranavir, ritonavir or their excipients
- Concomitant treatment with other experimental compounds
- Concomitant administration of any prescription or over the counter medications known to alter P450 enzyme or P-gp activity
- Concomitant administration of any prescription or over the counter medications known to be highly dependent on P450 or P-gp for clearance for which elevated plasma concentrations are known to be associated with serious toxicity
- Concomitant administration of any food product known to alter P450 enzyme or P-gp activity such as grapefruit juice, Seville oranges
- Concomitant administration of any drug that could affect bleeding (e.g., aspirin, clopidogrel, ticlopidine, warfarin, heparin, low-molecular weight heparin)
- Concomitant administration of oral contraceptives (may be included with 7-day washout period)
- Concomitant administration of any herbal medications
- Inadequate venous access
- Renal or hepatic insufficiency
- Clinically unacceptable result at the screening physical examination
- Use of investigational medications within 30 days before study entry
- HIV-positive
- Body Mass Index (BMI) > 30 kg/m²
About this study
Official title: Evaluating the Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity Using a Biomarker Cocktail in Healthy Human Volunteers
Primary: To quantify the influence of single-dose and steady-state tipranavir/ritonavir 500/200 mg on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp) biomarkers, as a means of predicting drug interactions. The AUCs for biomarkers caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin will be assessed.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tipranavir capsuleDrug
Tipranavir solutionDrug
Ritonavir capsuleDrug
CaffeineDrug
Warfarin sodiumDrug
Vitamin KDrug
OmeprazoleDrug
Dextromethorphan hydrobromideDrug
Midazolam injectionDrug
Midazolam oral solutionDrug
Digoxin tabletDrug
Digoxin injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | tipranavir (TPV) capsule + ritonavir (RTV) capsule + cocktail + digoxin oral Receives: Drug: Tipranavir capsule; Drug: Ritonavir capsule; Drug: Caffeine; Drug: Warfarin sodium; Drug: Vitamin K; Drug: Omeprazole; Drug: Dextromethorphan hydrobromide; Drug: Midazolam injection; Drug: Midazolam oral solution; Drug: Digoxin tablet |
| Treatment B | Experimental | TPV capsule + RTV capsule + cocktail + digoxin injection Receives: Drug: Tipranavir capsule; Drug: Ritonavir capsule; Drug: Caffeine; Drug: Warfarin sodium; Drug: Vitamin K; Drug: Omeprazole; Drug: Dextromethorphan hydrobromide; Drug: Midazolam injection; Drug: Midazolam oral solution; Drug: Digoxin injection |
| Treatment C | Experimental | TPV solution + RTV capsule + cocktail + digoxin oral Receives: Drug: Tipranavir solution; Drug: Ritonavir capsule; Drug: Caffeine; Drug: Warfarin sodium; Drug: Vitamin K; Drug: Omeprazole; Drug: Dextromethorphan hydrobromide; Drug: Midazolam injection; Drug: Midazolam oral solution; Drug: Digoxin tablet |
| Treatment D | Experimental | TPV solution + RTV capsule + cocktail + digoxin injection Receives: Drug: Tipranavir solution; Drug: Ritonavir capsule; Drug: Caffeine; Drug: Warfarin sodium; Drug: Vitamin K; Drug: Omeprazole; Drug: Dextromethorphan hydrobromide; Drug: Midazolam injection; Drug: Midazolam oral solution; Drug: Digoxin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve (AUC) at steady state
Measured: up to 72 hours
Secondary outcomes (7)
Plasma concentration after 12 hours (Cp12h)
Measured: 12 hours
Maximum plasma concentration (Cmax)
Measured: up to 12 hours
Time of maximum concentration (Tmax)
Measured: up to 72 hours
Apparent terminal half-life (t1/2)
Measured: up to 72 hours
Area under plasma concentration-time curve (AUC) after single dose
Measured: up to 72 hours
Change in biomarkers
Measured: baseline, up to 22 days
Change in enzyme activity
Measured: baseline, up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startJan 2006
- Primary completionJul 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT02243553
- Sponsor's protocol ID
- 1182.101
- Status last verified
- Aug 2014
- First submitted
- 1 Sep 2014
- Last updated
- 18 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity Using a Biomarker Cocktail in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT02243553
- Acronym / sponsor ID
- 1182.101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jul 2006 (actual)
- First posted
- 18 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.
Primary: To quantify the influence of single-dose and steady-state tipranavir/ritonavir 500/200 mg on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp) biomarkers, as a means of predicting drug interactions. The AUCs for biomarkers caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Tipranavir capsule, Drug: Ritonavir capsule, Drug: Caffeine, Drug: Warfarin sodium, Drug: Vitamin K, Drug: Omeprazole, Drug: Dextromethorphan hydrobromide, Drug: Midazolam injection, Drug: Midazolam oral solution, Drug: Digoxin tablettipranavir (TPV) capsule + ritonavir (RTV) capsule + cocktail + digoxin oral |
| Treatment B | Experimental | Drug: Tipranavir capsule, Drug: Ritonavir capsule, Drug: Caffeine, Drug: Warfarin sodium, Drug: Vitamin K, Drug: Omeprazole, Drug: Dextromethorphan hydrobromide, Drug: Midazolam injection, Drug: Midazolam oral solution, Drug: Digoxin injectionTPV capsule + RTV capsule + cocktail + digoxin injection |
| Treatment C | Experimental | Drug: Tipranavir solution, Drug: Ritonavir capsule, Drug: Caffeine, Drug: Warfarin sodium, Drug: Vitamin K, Drug: Omeprazole, Drug: Dextromethorphan hydrobromide, Drug: Midazolam injection, Drug: Midazolam oral solution, Drug: Digoxin tabletTPV solution + RTV capsule + cocktail + digoxin oral |
| Treatment D | Experimental | Drug: Tipranavir solution, Drug: Ritonavir capsule, Drug: Caffeine, Drug: Warfarin sodium, Drug: Vitamin K, Drug: Omeprazole, Drug: Dextromethorphan hydrobromide, Drug: Midazolam injection, Drug: Midazolam oral solution, Drug: Digoxin injectionTPV solution + RTV capsule + cocktail + digoxin injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Healthy subjects aged between 18 years and 45 years inclusive
- Weighing at least 50 kg
- Volunteers must be hospitalized on Days 1-4, 7-9, and 17-20 for pharmacokinetic assessments for each biomarker and TPV/r (Days 7-9 and 17-20)
- Volunteers must be willing to complete all study-related activities
Key exclusion criteria (25 listed)
- History or presence of allergy to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- History or diagnosis of any significant medical conditions: Including but not limited to gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, psychiatric, neurological, oncological or hormonal disorders
- Known elevated liver enzymes in past clinical trials with any compound (experimental or marketed)
- Clinically relevant laboratory abnormalities (e.g. Hgb<11g/dL, Hct<30g/dL, total cholesterol >240mg/dL, triglycerides >500mg/dL, fasting glucose >130mg/dL, liver function tests >2.5x upper limit of normal, baseline international normalized ratio >1.2)
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 capsule | Drug | Treatment A, Treatment B |
| Tipranavir solution | Drug | Treatment C, Treatment D |
| Ritonavir capsule | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| Caffeine | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| Warfarin sodium | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| Vitamin K | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| Omeprazole | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| Dextromethorphan hydrobromide | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| Midazolam injection | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| Midazolam oral solution | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| Digoxin tablet | Drug | Treatment A, Treatment C |
| Digoxin injection | Drug | Treatment B, Treatment D |
Primary outcome
Area under plasma concentration-time curve (AUC) at steady state
Time frame: up to 72 hours
7 secondary outcomes
Plasma concentration after 12 hours (Cp12h)
Time frame: 12 hours
Maximum plasma concentration (Cmax)
Time frame: up to 12 hours
Time of maximum concentration (Tmax)
Time frame: up to 72 hours
Apparent terminal half-life (t1/2)
Time frame: up to 72 hours
Area under plasma concentration-time curve (AUC) after single dose
Time frame: up to 72 hours
Change in biomarkers
Time frame: baseline, up to 22 days
Change in enzyme activity
Time frame: baseline, up to 22 days
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 18 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 capsule, Tipranavir solution and Ritonavir 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 7 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 18 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?
Area under plasma concentration-time curve (AUC) at steady state (time frame: up to 72 hours). 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 18 Sep 2014.