HealthyPhase 1NCT02251132
Pharmacokinetics of Tipranavir Soft Elastic Capsules (SEDDS) and Ritonavir and Their Effects on Cytochrome P-450 (3A4) in Healthy Volunteers
A Phase 1 study testing TPV low 1, TPV low 2 and TPV medium in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of this study is to establish the tipranavir-ritonavir steady-state dose-exposure relationships when administered on a b.i.d. dosing regimen; to determine the effects of tipranavir (TPV) and ritonavir (RTV) on cytochrome P-450 (CYP3A4) activity; to establish the dependency of the TPV M1 metabolite on RTV… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TPV low 1, TPV low 2 and TPV medium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Dec 2000
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 75 years of age inclusive
- Female subjects of child-bearing potential are required to use a barrier contraceptive method for at least 3 months prior to administration of study medication, during study medication administration and for 30 days after the end of the study
- Ability to swallow numerous large capsules without difficulty
- A body mass index (BMI) between 19 and 29 kg/m2
- Signed informed consent prior to trial participation
- Reasonable probability for completion of the study
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- Acceptable screening laboratory values that indicate adequate baseline organ function are required at the time of screening. Laboratory values are considered to be acceptable if severity is no higher than Grade 1 based on the AIDS Clinical Trials Group (ACTG) Grading Scale. All laboratory values > Grade 1 are subject to approval by the BIPI clinical monitor
- Acceptable medical history, physical examination, electrocardiogram, and chest X-ray are required prior to entering the treatment phase of 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
- Willingness to abstain from ingesting grapefruit or grapefruit juice for the duration of the study
- Urine drug screen negative for drugs of abuse
- Negative HIV serology
- Negative for Hepatitis B surface antigen and Hepatitis C antibody
Who cannot join
- Female subjects who:
- have a positive serum pregnancy test at Visits 1 or 2 OR
- are breastfeeding
- Receipt of any other investigational medicine for 30 days prior to Day 0
- Receipt of any known enzyme altering drug for 30 days prior to Day 0, grapefruit and grapefruit juice within 15 days prior to Day 0 and antibiotics within 10 days prior to Day 0
- Excessive cigarette smoking, defined as greater than 10 cigarettes per day
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- Blood or plasma donation within 30 days prior to Day 0
- Subjects with a seated systolic blood pressure either < 100 mg Hg or > 150 mm Hg; resting heart rate either < 50 beats/min or > 90 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 to the subject
- Subjects who have had an acute illness within 2 weeks prior to Day 0
- Subjects who are currently taking any over-the-counter drug within 7 days prior to Day 0, or who are currently taking any prescription drug that, in the opinion of the investigator in consultation with the BIPI medical monitor and pharmacokineticist, might interfere with either the absorption, distribution or metabolism of the test substances
- Hypersensitivity to tipranavir, ritonavir or sulfonamide containing drugs
- Evidence of active substance abuse that, in the investigator's opinion, could affect study adherence
About this study
Official title: An Open-label, Parallel Group, Multiple-dose Investigation of the Pharmacokinetics of Tipranavir Soft Elastic Capsules SEDDS and Ritonavir Soft Gel Capsules and Their Effects on Cytochrome P-450 (3A4) Activity in Normal Healthy Volunteers
The objective of this study is to establish the tipranavir-ritonavir steady-state dose-exposure relationships when administered on a b.i.d. dosing regimen; to determine the effects of tipranavir (TPV) and ritonavir (RTV) on cytochrome P-450 (CYP3A4) activity; to establish the dependency of the TPV M1 metabolite on RTV co-administration. Additionally, the short-term safety and tolerance of this drug combination will be evaluated.
- Conditions
- Healthy
- Being tested
- TPV low 1, TPV low 2, TPV medium, TPV high 1, TPV high 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPV low 1Drug
TPV low 2Drug
TPV mediumDrug
TPV high 1Drug
TPV high 2Drug
RTV lowDrug
Ritonavir highDrug
Radiolabelled erythromycinDrug
| Study group | Role | What they receive |
|---|---|---|
| TPV/RTV Low 1 | Experimental | Not described Receives: Drug: TPV low 1; Drug: Ritonavir high; Drug: Radiolabelled erythromycin |
| TPV/RTV Low 2 | Experimental | Not described Receives: Drug: TPV low 2; Drug: RTV low; Drug: Radiolabelled erythromycin |
| TPV/RTV Low 3 | Experimental | Not described Receives: Drug: TPV low 2; Drug: Ritonavir high; Drug: Radiolabelled erythromycin |
| TPV/RTV Medium 1 | Experimental | Not described Receives: Drug: TPV medium; Drug: RTV low; Drug: Radiolabelled erythromycin |
| TPV/RTV Medium 2 | Experimental | Not described Receives: Drug: TPV medium; Drug: Ritonavir high; Drug: Radiolabelled erythromycin |
| TPV/RTV High 1 | Experimental | Not described Receives: Drug: TPV high 1; Drug: RTV low; Drug: Radiolabelled erythromycin |
| TPV/RTV High 2 | Experimental | Not described Receives: Drug: TPV high 1; Drug: Ritonavir high; Drug: Radiolabelled erythromycin |
| TPV/RTV High 3 | Experimental | Not described Receives: Drug: TPV high 2; Drug: Ritonavir high; Drug: Radiolabelled erythromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough plasma concentration at steady state (Cmin,ss)
Measured: up to 24 hours
Maximum plasma concentration at steady state (Cmax,ss)
Measured: up to 24 hours
Time of maximum concentration (tmax)
Measured: up to 24 hours
Area under the plasma concentration time curve from 0 to 12 hours (AUC0-12)
Measured: up to 12 hours
Secondary outcomes (5)
Oral clearance (Cl/F)
Measured: up to 24 hours
Apparent terminal half life (t1/2)
Measured: up to 24 hours
Percent of erythromycin metabolized per hour
Erythromycin breath test (ERMBT)
Measured: up to 24 hours
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 32 days
Number of subjects with adverse events
Measured: up to 32 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 startOct 2000
- Primary completionDec 2000
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
- 113 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
- NCT02251132
- Sponsor's protocol ID
- 1182.5
- 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
- An Open-label, Parallel Group, Multiple-dose Investigation of the Pharmacokinetics of Tipranavir Soft Elastic Capsules SEDDS and Ritonavir Soft Gel Capsules and Their Effects on Cytochrome P-450 (3A4) Activity in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02251132
- Acronym / sponsor ID
- 1182.5
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- Dec 2000 (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.
The objective of this study is to establish the tipranavir-ritonavir steady-state dose-exposure relationships when administered on a b.i.d. dosing regimen; to determine the effects of tipranavir (TPV) and ritonavir (RTV) on cytochrome P-450 (CYP3A4) activity; to establish the dependency of the TPV M1 metabolite on RTV co-administration. Additionally, the short-term safety and tolerance of this drug combination will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| TPV/RTV Low 1 | Experimental | Drug: TPV low 1, Drug: Ritonavir high, Drug: Radiolabelled erythromycin |
| TPV/RTV Low 2 | Experimental | Drug: TPV low 2, Drug: RTV low, Drug: Radiolabelled erythromycin |
| TPV/RTV Low 3 | Experimental | Drug: TPV low 2, Drug: Ritonavir high, Drug: Radiolabelled erythromycin |
| TPV/RTV Medium 1 | Experimental | Drug: TPV medium, Drug: RTV low, Drug: Radiolabelled erythromycin |
| TPV/RTV Medium 2 | Experimental | Drug: TPV medium, Drug: Ritonavir high, Drug: Radiolabelled erythromycin |
| TPV/RTV High 1 | Experimental | Drug: TPV high 1, Drug: RTV low, Drug: Radiolabelled erythromycin |
| TPV/RTV High 2 | Experimental | Drug: TPV high 1, Drug: Ritonavir high, Drug: Radiolabelled erythromycin |
| TPV/RTV High 3 | Experimental | Drug: TPV high 2, Drug: Ritonavir high, Drug: Radiolabelled erythromycin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female between 18 and 75 years of age inclusive
- Female subjects of child-bearing potential are required to use a barrier contraceptive method for at least 3 months prior to administration of study medication, during study medication administration and for 30 days after the end of the study
- Ability to swallow numerous large capsules without difficulty
- A body mass index (BMI) between 19 and 29 kg/m2
- Signed informed consent prior to trial participation
Key exclusion criteria (13 listed)
- Female subjects who:
- Receipt of any other investigational medicine for 30 days prior to Day 0
- Receipt of any known enzyme altering drug for 30 days prior to Day 0, grapefruit and grapefruit juice within 15 days prior to Day 0 and antibiotics within 10 days prior to Day 0
- Excessive cigarette smoking, defined as greater than 10 cigarettes per day
- Blood or plasma donation within 30 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 low 1 | Drug | TPV/RTV Low 1 |
| TPV low 2 | Drug | TPV/RTV Low 2, TPV/RTV Low 3 |
| TPV medium | Drug | TPV/RTV Medium 1, TPV/RTV Medium 2 |
| TPV high 1 | Drug | TPV/RTV High 1, TPV/RTV High 2 |
| TPV high 2 | Drug | TPV/RTV High 3 |
| RTV low | Drug | TPV/RTV High 1, TPV/RTV Low 2, TPV/RTV Medium 1 |
| Ritonavir high | Drug | TPV/RTV High 2, TPV/RTV High 3, TPV/RTV Low 1, TPV/RTV Low 3, TPV/RTV Medium 2 |
| Radiolabelled erythromycin | Drug | TPV/RTV High 1, TPV/RTV High 2, TPV/RTV High 3, TPV/RTV Low 1, TPV/RTV Low 2, TPV/RTV Low 3, TPV/RTV Medium 1, TPV/RTV Medium 2 |
Primary outcome
Trough plasma concentration at steady state (Cmin,ss)
Time frame: up to 24 hours
Maximum plasma concentration at steady state (Cmax,ss)
Time frame: up to 24 hours
Time of maximum concentration (tmax)
Time frame: up to 24 hours
Area under the plasma concentration time curve from 0 to 12 hours (AUC0-12)
Time frame: up to 12 hours
5 secondary outcomes
Oral clearance (Cl/F)
Time frame: up to 24 hours
Apparent terminal half life (t1/2)
Time frame: up to 24 hours
Percent of erythromycin metabolized per hour
Time frame: up to 24 hours
Number of subjects with clinically significant findings in laboratory tests
Time frame: up to 32 days
Number of subjects with adverse events
Time frame: up to 32 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 TPV low 1, TPV low 2 and TPV medium 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 13 inclusion and 13 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?
Trough plasma concentration at steady state (Cmin,ss) (time frame: up to 24 hours). 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 29 Sep 2014.