HealthyPhase 1NCT02251145
Effects of Tipranavir (TPV) and Ritonavir (RTV) on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate in Healthy Volunteers
A Phase 1 study testing Tipranavir low dose, Tipranavir high dose and Ritonavir low dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to characterise the effects of two dose combinations of tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered BID, on the pharmacokinetics of tenofovir disoproxil fumarate as well as the effects of tenofovir disoproxil fumarate on the pharmacokinetics of tipranavir/ritonavir. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tipranavir low dose, Tipranavir high dose and Ritonavir low dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Jun 2002
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability and willingness to give written informed consent in accordance with institutional and regulatory guidelines and to comply with the investigational nature of the study and the related requirements
- Healthy males or females between 18 and 60 years of age inclusive
- A Body Mass Index >18.5 and <30 kg/m2
- Ability to swallow numerous large capsules without difficulty
- Reasonable probability for completion of the study, in the opinion of the investigator
- Acceptable laboratory values that indicate adequate baseline organ function are required at the time of screening. Laboratory values are considered to be acceptable if severity <= Grade1 based on the AIDS Clinical Trials Group (ACTG) Division of AIDS (DAIDS) Grading Scale. All abnormal laboratory values > Grade 1 (e.g., creatine phosphokinase (CPK), amylase, triglycerides) are subject to approval by the BIPI clinical monitor. Cholesterol <= 240mg/dL at the time of screening is necessary for study entry
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- Acceptable medical history, physical examination and ECG are required prior to entering the study
- Willingness to abstain from alcohol for 48 hours prior to Study Day 0 and abstain from alcohol for the duration of the study. In addition, Cabernet Sauvignon must not have been ingested within 15 days prior to Day 0 (Visit 2)
- Willingness to abstain from ingesting grapefruit and grapefruit juice within 15 days of Day 0, Visit 2 and for the duration of the study
- Willingness to abstain from ingesting Seville oranges, strawberries or strawberry extract, garlic supplements, St. John's Wort, Milk Thistle, or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) within 72 hours of pharmacokinetic (PK) sampling days
- Willingness to abstain from use of tobacco products for the duration of the study
- Urine drug screen negative for illegal non-prescription drugs
- Negative HIV serology
- Negative for Hepatitis B surface antigen and Hepatitis C
Who cannot join
- Female subjects who are of reproductive potential who:
- Have a positive serum B-HCG at Visit 1 or 2 or
- Have not been using regular oral contraception (combined oestrogen and progestogen pill or progestogen only pill) for 3 months and a barrier contraceptive method for at least 30 days prior to Visit 3 (Day 1) or a barrier contraceptive method for at least 3 months prior to Visit 3 (Day 1) or
- Are not willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam)during the trial and 30 days after completion/termination or
- Are breast-feeding
- Participation in another trial with an investigational medicine for 30 days prior to Day 0 (Visit 2)
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- Ingestion of any known enzyme altering drug (such as phenothiazines, cimetidine, barbiturates, ketoconazole, fluconazole, rifampin, steroids, and herbal medications) for 30 days prior to Day 0 (Visit 2). Use of any other herbal/complementary treatment must be discussed in advance with the monitor and permission obtained prior to study entry
- Ingestion of grapefruit, grapefruit juice, and Cabernet Sauvignon within 15 days prior to Day 0 (Visit 2)
- Ingestion of Seville oranges, strawberries or strawberry extract, garlic supplements, St. John's Wort, Milk Thistle, or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) within 72 hours of PK sampling days
- Ingestion of antibiotics within 10 days prior to Day 0 (Visit 2)
- Inability to comply with investigator's instructions
- History of gastrointestinal, hepatic, or renal disorders within 60 days
- History of alcohol abuse
- Current use of cigarettes defined as greater than 10 cigarettes per day or rolling/pipe tobacco equivalent
- Blood or plasma donations within 30 days prior to Day 0 (Visit 2)
- Subjects with a seated systolic blood pressure either <100 mm Hg or >150 mm Hg; resting heart rate either <50 beats/min or >100 beats/min
- 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 or ritonavir or tenofovir disoproxil fumarate to the subject
- Subjects who have had an acute illness within 2 weeks prior to Day 0 (Visit 2)
- Subjects who are currently taking any over-the-counter drug within 7 days prior to Day 0, (Visit 2) or who are currently taking any prescription drug that, in the opinion of the investigator in consultation with the clinical monitor and pharmacokineticist, might interfere with either the absorption, distribution or metabolism of the test substances
- Hypersensitivity to tipranavir, ritonavir, or tenofovir disoproxil fumarate
About this study
Official title: A Single Centre, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effects of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg Twice a Day for 11.5 Days on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate 300 mg in Healthy Volunteers
Study to characterise the effects of two dose combinations of tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered BID, on the pharmacokinetics of tenofovir disoproxil fumarate as well as the effects of tenofovir disoproxil fumarate on the pharmacokinetics of tipranavir/ritonavir.
- Conditions
- Healthy
- Being tested
- Tipranavir low dose, Tipranavir high dose, Ritonavir low dose, Ritonavir high dose, Tenofovir disoproxil fumarate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tipranavir low doseDrug
Tipranavir high doseDrug
Ritonavir low doseDrug
Ritonavir high doseDrug
Tenofovir disoproxil fumarateDrug
| Study group | Role | What they receive |
|---|---|---|
| tipranavir/ritonavir low dose | Experimental | Not described Receives: Drug: Tipranavir low dose; Drug: Ritonavir low dose; Drug: Tenofovir disoproxil fumarate |
| tipranavir/ritonavir high dose | Experimental | Not described Receives: Drug: Tipranavir high dose; Drug: Ritonavir high dose; Drug: Tenofovir disoproxil fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration time curve from 0-24 hours (AUC0-24) for tenofovir
Measured: up to 24 hours
Area under plasma concentration time curve from 0-12hours (AUC0-12) for tipranavir/ritonavir
Measured: up to 12 hours
Maximum plasma concentration (Cmax)
Measured: up to 24 hours
Drug concentration in plasma at 12 hours after administration (C12h) for tenofovir
Measured: up to 12 hours
Drug concentration in plasma at 12 hours after administration (C12h) for tipranavir/ritonavir
Measured: up to 12 hours
Secondary outcomes (12)
Maximum plasma concentration at steady state (Cmax,ss)
Measured: up to 24 hours
Trough plasma concentration at steady state (Cmin)
Measured: up to 24 hours
Mean residency time (MRT)
Measured: up to 24 hours
Apparent terminal half life (T1/2)
Measured: up to 24 hours
Time of maximum concentration (Tmax)
Measured: up to 24 hours
Oral clearance (CL/F)
Measured: up to 24 hours
Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
Measured: up to 24 hours
Number of subjects with clinically significant findings in vital signs (pulse rate, blood pressure)
Measured: up to 14 days
Number of subjects with clinically significant findings in physical examination
Measured: up to 14 days
Number of subjects with clinically significant findings in electrocardiogram
Measured: up to 14 days
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 14 days
Number of subjects with adverse events
Measured: up to 14 days
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 startMay 2002
- Primary completionJun 2002
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
- 49 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
- NCT02251145
- Sponsor's protocol ID
- 1182.46
- 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
- A Single Centre, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effects of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg Twice a Day for 11.5 Days on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate 300 mg in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02251145
- Acronym / sponsor ID
- 1182.46
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Jun 2002 (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 characterise the effects of two dose combinations of tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered BID, on the pharmacokinetics of tenofovir disoproxil fumarate as well as the effects of tenofovir disoproxil fumarate on the pharmacokinetics of tipranavir/ritonavir.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tipranavir/ritonavir low dose | Experimental | Drug: Tipranavir low dose, Drug: Ritonavir low dose, Drug: Tenofovir disoproxil fumarate |
| tipranavir/ritonavir high dose | Experimental | Drug: Tipranavir high dose, Drug: Ritonavir high dose, Drug: Tenofovir disoproxil fumarate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Ability and willingness to give written informed consent in accordance with institutional and regulatory guidelines and to comply with the investigational nature of the study and the related requirements
- Healthy males or females between 18 and 60 years of age inclusive
- A Body Mass Index >18.5 and <30 kg/m2
- Ability to swallow numerous large capsules without difficulty
- Reasonable probability for completion of the study, in the opinion of the investigator
Key exclusion criteria (20 listed)
- Female subjects who are of reproductive potential who:
- Participation in another trial with an investigational medicine for 30 days prior to Day 0 (Visit 2)
- Ingestion of any known enzyme altering drug (such as phenothiazines, cimetidine, barbiturates, ketoconazole, fluconazole, rifampin, steroids, and herbal medications) for 30 days prior to Day 0 (Visit 2). Use of any other herbal/complementary treatment must be discussed in advance with the monitor and permission obtained prior to study entry
- Ingestion of grapefruit, grapefruit juice, and Cabernet Sauvignon within 15 days prior to Day 0 (Visit 2)
- Ingestion of Seville oranges, strawberries or strawberry extract, garlic supplements, St. John's Wort, Milk Thistle, or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) within 72 hours of PK sampling days
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 low dose | Drug | tipranavir/ritonavir low dose |
| Tipranavir high dose | Drug | tipranavir/ritonavir high dose |
| Ritonavir low dose | Drug | tipranavir/ritonavir low dose |
| Ritonavir high dose | Drug | tipranavir/ritonavir high dose |
| Tenofovir disoproxil fumarate | Drug | tipranavir/ritonavir high dose, tipranavir/ritonavir low dose |
Primary outcome
Area under plasma concentration time curve from 0-24 hours (AUC0-24) for tenofovir
Time frame: up to 24 hours
Area under plasma concentration time curve from 0-12hours (AUC0-12) for tipranavir/ritonavir
Time frame: up to 12 hours
Maximum plasma concentration (Cmax)
Time frame: up to 24 hours
Drug concentration in plasma at 12 hours after administration (C12h) for tenofovir
Time frame: up to 12 hours
Drug concentration in plasma at 12 hours after administration (C12h) for tipranavir/ritonavir
Time frame: up to 12 hours
12 secondary outcomes
Maximum plasma concentration at steady state (Cmax,ss)
Time frame: up to 24 hours
Trough plasma concentration at steady state (Cmin)
Time frame: up to 24 hours
Mean residency time (MRT)
Time frame: up to 24 hours
Apparent terminal half life (T1/2)
Time frame: up to 24 hours
Time of maximum concentration (Tmax)
Time frame: up to 24 hours
Oral clearance (CL/F)
Time frame: up to 24 hours
Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
Time frame: up to 24 hours
Number of subjects with clinically significant findings in vital signs (pulse rate, blood pressure)
Time frame: up to 14 days
Number of subjects with clinically significant findings in physical examination
Time frame: up to 14 days
Number of subjects with clinically significant findings in electrocardiogram
Time frame: up to 14 days
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 14 days
Number of subjects with adverse events
Time frame: up to 14 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 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 low dose, Tipranavir high dose and Ritonavir low dose 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 20 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?
Area under plasma concentration time curve from 0-24 hours (AUC0-24) for tenofovir (time frame: up to 24 hours). The study lists 5 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.