HealthyPhase 1NCT02253862
Pharmacokinetic of Tadalafil Co-administered With Tipranavir/Ritonavir to Healthy Male Volunteers
A Phase 1 study testing Tadalafil, Tipranavir and Ritonavir in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to assess the effects of single-dose and steady-state tipranavir/ritonavir 500 mg/200 mg on the single-dose pharmacokinetics of tadalafil 10 mg Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tadalafil, Tipranavir and Ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Mar 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- Healthy male subjects aged between 18 years and 55 years inclusive
- Weighing at least 40 kg
- Volunteers must be hospitalized on day of pharmacokinetic assessments for each regimen
- Volunteers must be willing to complete all study-related activities
- Each volunteer must have a valid social security regimen
- Each volunteer must have acceptable medical history, physical examination and laboratory test
- Volunteers with negative HIV serology
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. (If heparin is used during pharmacokinetic (PK) sampling, subjects with a history of sensibility to heparin or heparin-induced thrombocytopenia should not be enrolled)
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders
- Known elevated liver enzymes in past clinical trials with any compound (experimental or marketed)
- Clinically relevant laboratory abnormalities and all abnormal laboratory values >Grade 1, based on the Division of AIDS Grading Scale
- Subjects with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering tipranavir, ritonavir or tadalafil to the subject
Show all 15Show fewer
- Volunteers who are using any form of organic nitrate, either regularly and/or intermittently (contraindication to use tadalafil)
- Hypersensitivity to tadalafil, tipranavir, ritonavir or their excipients
- Concurrent treatment with other experimental compounds
- Inadequate venous access
- Contraindications to tadalafil: Volunteers with mild or moderate hepatic impairment, Renal insufficiency or Cardiovascular disease (patients with a myocardial infarction within the last 90 days, unstable angina or angina occurring during sexual intercourse, patients with New York Heart Association Class 2 or greater heart failure in the last 6 months, patients with uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension (>170/100 mm Hg), and patients with a stroke within the last 6 months)
- Clinically unacceptable result at the screening physical examination
- Use of investigational medications within 30 days before study entry
- Patients hospitalized in a medical or social establishment, for any other reason than research
- People deprived of judicial or administrative freedom.
About this study
Official title: Assessment of Single-dose Oral Tadalafil Pharmacokinetic Characteristics When Simultaneously Co-administered With Single-dose and Steady-state Tipranavir/Ritonavir 500 mg/200 mg to Healthy Male Volunteers
Study to assess the effects of single-dose and steady-state tipranavir/ritonavir 500 mg/200 mg on the single-dose pharmacokinetics of tadalafil 10 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
administered days 1, 8 and 16
TipranavirDrug
administered days 8-18
RitonavirDrug
administered days 8-18
| Study group | Role | What they receive |
|---|---|---|
| Sequential treatment | Experimental | Not described Receives: Drug: Tadalafil; Drug: Tipranavir; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) for Tadalafil
Measured: up to 72 hours after drug administration
Plasma Concentration (Cp12h) for Tadalafil
Measured: 12 hours after drug administration
Area Under Plasma Concentration-time Curve (AUC0-72h) for Tadalafil
Measured: up to 72 hours after drug administration
AUC0-∞ for Tadalafil
Measured: up to 72 hours after drug administration
Secondary outcomes (8)
Cmax for Tipranavir and Ritonavir
Measured: up to 12 hours after drug administration
Cp12 for Tipranavir and Ritonavir
Measured: 12 hours after drug administration
AUC0-12hTipranavir and Ritonavir
Measured: 12 hours after drug administration
Time of Maximum Concentration
Measured: up to 72 hours after drug administration
Elimination half-life (t1/2)
Measured: up to 72 hours after drug administration
Total body clearance (Cl/F)
Measured: up to 72 hours after drug administration
Volume of distribution,
Measured: up to 72 hours after drug administration
Number of subjects with adverse events
Measured: up to 42 days
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 startDec 2005
- Primary completionMar 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT02253862
- Sponsor's protocol ID
- 1182.83
- Status last verified
- Sep 2014
- First submitted
- 30 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
- Assessment of Single-dose Oral Tadalafil Pharmacokinetic Characteristics When Simultaneously Co-administered With Single-dose and Steady-state Tipranavir/Ritonavir 500 mg/200 mg to Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02253862
- Acronym / sponsor ID
- 1182.83
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Mar 2006 (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 assess the effects of single-dose and steady-state tipranavir/ritonavir 500 mg/200 mg on the single-dose pharmacokinetics of tadalafil 10 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential treatment | Experimental | Drug: Tadalafil, Drug: Tipranavir, Drug: Ritonavir |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Healthy male subjects aged between 18 years and 55 years inclusive
- Weighing at least 40 kg
- Volunteers must be hospitalized on day of pharmacokinetic assessments for each regimen
- Volunteers must be willing to complete all study-related activities
Key exclusion criteria (15 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. (If heparin is used during pharmacokinetic (PK) sampling, subjects with a history of sensibility to heparin or heparin-induced thrombocytopenia should not be enrolled)
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders
- Known elevated liver enzymes in past clinical trials with any compound (experimental or marketed)
- Clinically relevant laboratory abnormalities and all abnormal laboratory values >Grade 1, based on the Division of AIDS Grading Scale
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 |
|---|---|---|
| Tadalafiladministered days 1, 8 and 16 | Drug | Sequential treatment |
| Tipranaviradministered days 8-18 | Drug | Sequential treatment |
| Ritonaviradministered days 8-18 | Drug | Sequential treatment |
Primary outcome
Maximum Plasma Concentration (Cmax) for Tadalafil
Time frame: up to 72 hours after drug administration
Plasma Concentration (Cp12h) for Tadalafil
Time frame: 12 hours after drug administration
Area Under Plasma Concentration-time Curve (AUC0-72h) for Tadalafil
Time frame: up to 72 hours after drug administration
AUC0-∞ for Tadalafil
Time frame: up to 72 hours after drug administration
8 secondary outcomes
Cmax for Tipranavir and Ritonavir
Time frame: up to 12 hours after drug administration
Cp12 for Tipranavir and Ritonavir
Time frame: 12 hours after drug administration
AUC0-12hTipranavir and Ritonavir
Time frame: 12 hours after drug administration
Time of Maximum Concentration
Time frame: up to 72 hours after drug administration
Elimination half-life (t1/2)
Time frame: up to 72 hours after drug administration
Total body clearance (Cl/F)
Time frame: up to 72 hours after drug administration
Volume of distribution,
Time frame: up to 72 hours after drug administration
Number of subjects with adverse events
Time frame: up to 42 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 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 Tadalafil, 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 8 inclusion and 15 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?
Maximum Plasma Concentration (Cmax) for Tadalafil (time frame: up to 72 hours after drug administration). The study lists 4 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.