HealthyPhase 1NCT02253797
Pharmacokinetics of Tipranavir/Ritonavir and Its Metabolites in Healthy Male Subjects
A Phase 1 study testing 14C-Tipranavir, Tipranavir and Ritonavir in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to evaluate the pharmacokinetics of Tipranavir and its metabolites including excretion and mass balance of parent compound and radioactivity at steady-state; to isolate, identify and quantify major metabolites of tipranavir in plasma, urine and feces Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 14C-Tipranavir, Tipranavir and Ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 2003to Jul 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy HIV-negative male subjects as determined by results of screening. Healthiness was determined by medical history, laboratory testing and 12-lead ECG
- Signed written informed consent in accordance with Good Clinical Practice (GCP)
- Age >18 and <=60 years
- Subjects within 20% of the normal height: weight range defined by the Metropolitan Life Insurance Company Tables
- Ability to swallow numerous large capsules
- Willingness to abstain from smoking, ingesting methylxanthine containing drinks or food (coffee, tea, cola, chocolate, etc.), or ingesting alcohol, St. John's Wort, milk thistle, garlic supplements, Seville oranges, and grapefruit or grapefruit juice for the duration of the study
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate, and ECG) deviating from normal and of clinical relevance
- History of clinically significant disease including metabolic, endocrinologic, immunological, hepatic, renal, gastrointestinal, respiratory, cardiovascular, psychiatric or neurological
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator and/or the sponsor
- Subjects with a history of drug abuse or alcoholism
- Chronic or relevant acute (within 2 weeks of screening) infections
- Subjects who have taken prescription medications, over-the-counter drugs, or herbal preparations within 2 weeks of the start of the trial
Show all 11Show fewer
- Participation in another trial with an investigational drug (in the 30 days prior to screening)
- Blood donation >400 mL (within 1 month prior to treatment administration or during the trial)
- Any laboratory value that represents a Division of DAIDS (DAIDS) toxicity Grade >1
- Positive urine drug screen, positive HIV antibody, positive Hepatitis C Ribonucleic acid (RNA), or positive Hepatitis B surface antigen
- History of any familial bleeding disorder
About this study
Official title: A Phase I Multiple Oral Dose Trial of Tipranavir 500 mg/Ritonavir 200 mg Dosed to Steady State Followed by Single-dose 14C-radiolabeled Tipranavir Co-administered With Tipranavir 500 mg/Ritonavir 200 mg to Characterize the Excretion Balance and Metabolite Profile of 14C-radiolabeled Tipranavir in Healthy Male Subjects
Study to evaluate the pharmacokinetics of Tipranavir and its metabolites including excretion and mass balance of parent compound and radioactivity at steady-state; to isolate, identify and quantify major metabolites of tipranavir in plasma, urine and feces
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-TipranavirDrug
TipranavirDrug
RitonavirDrug
| Study group | Role | What they receive |
|---|---|---|
| TPV/r followed by 14C-radiolabeled TPV | Experimental | Tipranavir/Ritonavir dosed to steady state followed by single-dose 14C-radiolabeled tipranavir co-administered with Tipranavir/Ritonavir Receives: Drug: 14C-Tipranavir; Drug: Tipranavir; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioactive levels of 14C-Tipranavir in plasma and blood
Measured: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Radioactive erythrocyte-plasma partition ratio
Measured: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Maximum measured concentration of the analyte in plasma (Cmax)
14C-radiolabeled Tipranavir + Tipranavir
Measured: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Plasma concentration 12 hours after dosing (Cp12h)
14C-radiolabeled Tipranavir + Tipranavir
Measured: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Area under plasma concentration time curve (AUC)
14C-radiolabeled Tipranavir + Tipranavir
Measured: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Time of maximum concentration (Tmax)
14C-radiolabeled Tipranavir + Tipranavir
Measured: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Apparent terminal half life (t1/2)
14C-radiolabeled Tipranavir + Tipranavir
Measured: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Cumulative amount of 14C- radioactivity in Urine and feces
Measured: up to 15 days
Percent excretion in urine and feces
relative to total radioactivity administered
Measured: up to 15 days
Time needed to achieve steady-state as determined by tipranavir trough concentrations
Measured: up to 15 days
Secondary outcomes (3)
Number of subjects with adverse events
Measured: up to 15 days
Number of subjects with abnormal changes in laboratory parameters
Measured: up to day 14
Number of subjects with clinically significant changes in Electrocardiogram (ECG)
Measured: up to day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startJul 2003
- Primary completionJul 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253797
- Sponsor's protocol ID
- 1182.24
- Status last verified
- Sep 2014
- First submitted
- 25 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Multiple Oral Dose Trial of Tipranavir 500 mg/Ritonavir 200 mg Dosed to Steady State Followed by Single-dose 14C-radiolabeled Tipranavir Co-administered With Tipranavir 500 mg/Ritonavir 200 mg to Characterize the Excretion Balance and Metabolite Profile of 14C-radiolabeled Tipranavir in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02253797
- Acronym / sponsor ID
- 1182.24
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Jul 2003 (actual)
- First posted
- 1 Oct 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 evaluate the pharmacokinetics of Tipranavir and its metabolites including excretion and mass balance of parent compound and radioactivity at steady-state; to isolate, identify and quantify major metabolites of tipranavir in plasma, urine and feces
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPV/r followed by 14C-radiolabeled TPV | Experimental | Drug: 14C-Tipranavir, Drug: Tipranavir, Drug: RitonavirTipranavir/Ritonavir dosed to steady state followed by single-dose 14C-radiolabeled tipranavir co-administered with Tipranavir/Ritonavir |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy HIV-negative male subjects as determined by results of screening. Healthiness was determined by medical history, laboratory testing and 12-lead ECG
- Signed written informed consent in accordance with Good Clinical Practice (GCP)
- Age >18 and <=60 years
- Subjects within 20% of the normal height: weight range defined by the Metropolitan Life Insurance Company Tables
- Ability to swallow numerous large capsules
Key exclusion criteria (11 listed)
- Any finding of the medical examination (including blood pressure, pulse rate, and ECG) deviating from normal and of clinical relevance
- History of clinically significant disease including metabolic, endocrinologic, immunological, hepatic, renal, gastrointestinal, respiratory, cardiovascular, psychiatric or neurological
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator and/or the sponsor
- Subjects with a history of drug abuse or alcoholism
- Chronic or relevant acute (within 2 weeks of screening) 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 |
|---|---|---|
| 14C-Tipranavir | Drug | TPV/r followed by 14C-radiolabeled TPV |
| Tipranavir | Drug | TPV/r followed by 14C-radiolabeled TPV |
| Ritonavir | Drug | TPV/r followed by 14C-radiolabeled TPV |
Primary outcome
Radioactive levels of 14C-Tipranavir in plasma and blood
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Radioactive erythrocyte-plasma partition ratio
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
14C-radiolabeled Tipranavir + Tipranavir
Plasma concentration 12 hours after dosing (Cp12h)
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
14C-radiolabeled Tipranavir + Tipranavir
Area under plasma concentration time curve (AUC)
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
14C-radiolabeled Tipranavir + Tipranavir
Time of maximum concentration (Tmax)
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
14C-radiolabeled Tipranavir + Tipranavir
Apparent terminal half life (t1/2)
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
14C-radiolabeled Tipranavir + Tipranavir
Cumulative amount of 14C- radioactivity in Urine and feces
Time frame: up to 15 days
Percent excretion in urine and feces
Time frame: up to 15 days
relative to total radioactivity administered
Time needed to achieve steady-state as determined by tipranavir trough concentrations
Time frame: up to 15 days
3 secondary outcomes
Number of subjects with adverse events
Time frame: up to 15 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to day 14
Number of subjects with clinically significant changes in Electrocardiogram (ECG)
Time frame: up to day 6
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 1 Oct 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 14C-Tipranavir, Tipranavir and Ritonavir 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 6 inclusion and 11 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 1 Oct 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?
Radioactive levels of 14C-Tipranavir in plasma and blood (time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration). The study lists 10 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 1 Oct 2014.