HealthyPhase 1NCT02251119
The Pharmacodynamic/Pharmacokinetic Interaction of Tipranavir and Ritonavir With Loperamide in Healthy Volunteers
A Phase 1 study testing Tipranavir, Ritonavir and Loperamide in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of the study was to determine if the co-administration of loperamide (LOP) with tipranavir (TPV), ritonavir (RTV), or TPV plus RTV (TPV/r) caused a clinically significant change in the respiratory response to carbon dioxide (CO2), defined as a 10% decrease in the area under the pharmacodynamic… 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, Ritonavir and Loperamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Jan 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
- 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 federal 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 (BMI) between 18 and 35 kg/m2
- Ability to perform a respiratory depression test
- Ability to swallow numerous large capsules without difficulty
- In the opinion of the investigator, a reasonable probability for completion of the study
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- Acceptable laboratory values that indicated adequate baseline organ function were required at the time of screening. Laboratory values were considered to be acceptable if their severity was ≤Grade 1 based on the AIDS Clinical Trials Group Division of AIDS (DAIDS) Grading Scale. All abnormal laboratory values >Grade 1 (e.g., creatinine phosphokinase, amylase, triglycerides) were subject to approval by the clinical monitor or designee
- Acceptable medical history, physical examination, ECG, and chest x-ray were required prior to entering the study
- Willingness to abstain from alcohol from Day -2 to Day 24. In addition, red wine must not have been ingested within 14 days prior to Day 1 (Visit 2)
- Willingness to abstain from ingesting grapefruit, grapefruit juice, Seville oranges, St. John's Wort and Milk Thistle, within 14 days of Day 1 (Visit 2) and for the duration of the study
- Willingness to abstain from ingesting garlic supplements, or methylxanthine containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) within 72 hours of pharmacokinetic (PK) sampling days (Day 1 [Visit 2], Day 9 [Visit 3], Day 21-22 [Visit 4])
- Willingness to abstain from the use of tobacco products for the duration of the study
- Nonsmoker
- Urine drug screen negative for illegal nonprescription drugs
- Negative HIV serology
- Negative serology for hepatitis B surface antigen and hepatitis C
Who cannot join
- Female subjects who were of reproductive potential who:
- Had a positive serum β-human chorionic gonadotropin test at Visit 1, or
- Had not been using a barrier contraceptive method for at least 3 months prior to Visit 2 (Day 1), or
- Were not willing to use a reliable method of double-barrier contraception (such as a diaphragm with spermicidal cream/jelly or condoms with spermicidal foam) during the trial and 30 days after completion/termination of the trial, or
- Were breast-feeding
- Participation in another trial with an investigational medicine for 30 days prior to Day 1 (Visit 2)
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- Ingestion of any known enzyme-altering drug listed in the protocol 30 days prior to Day 1 (Visit 2)
- Ingestion of grapefruit, grapefruit juice, St. John's Wort, Milk Thistle, Seville oranges and red wine within 14 days prior to Day 1 (Visit 2)
- Ingestion of garlic supplements or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) within 72 hours of PK sampling days (Day 1 [Visit 2], Day 9 [Visit 3], Day 21-22 [Visit 4])
- Ingestion of antibiotics within 10 days prior to Day 1 (Visit 2)
- Inability to comply with investigator's instructions
- History of gastrointestinal, hepatic, or renal disorders within 60 days of study entry
- Recent or active alcohol abuse
- Current use of tobacco products
- Blood or plasma donations within 30 days prior to Day 1 (Visit 2)
- Seated systolic blood pressure either <100 mm Hg or >150 mm Hg; resting heart rate either <50 beats/min or >90 beats/min
- A history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering TPV or RTV or LOP to the subject
- An acute illness within 2 weeks prior to Day 1 (Visit 2)
- Current taking of any over-the-counter drug within 7 days prior to Day 1 (Visit 2) or current taking of 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 TPV, RTV, or LOP
- Administration of any antidiarrheal agent within 7 days of Day 1 (Visit 2)
- Hypersensitivity to sulfonamide drugs
About this study
The objective of the study was to determine if the co-administration of loperamide (LOP) with tipranavir (TPV), ritonavir (RTV), or TPV plus RTV (TPV/r) caused a clinically significant change in the respiratory response to carbon dioxide (CO2), defined as a 10% decrease in the area under the pharmacodynamic effect/time curve or at least a 25% decrease in at least one pharmacodynamic time point.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TipranavirDrug
RitonavirDrug
LoperamideDrug
| Study group | Role | What they receive |
|---|---|---|
| TPV | Experimental | Administration of LOP on days 1, 9 and 22
Administration of TPV on days 4-9
Administration of TPV/RTV on days 12-22 Receives: Drug: Tipranavir; Drug: Ritonavir; Drug: Loperamide |
| RTV | Experimental | Administration of LOP on days 1, 9 and 22
Administration of RTV on days 4-9
Administration of TPV/RTV on days 12-22 Receives: Drug: Tipranavir; Drug: Ritonavir; Drug: Loperamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum decrease in the percentage baseline CO2 response slope
rebreathing test
Measured: up to 6 hours on days 1, 9 and 22
Zero-to-six hour area under the curve for the percentage baseline CO2 response slope profile
Measured: up to 6 hours on days 1, 9 and 22
Secondary outcomes (8)
Change in the ratio between the diameter of the iris and pupil
up to 6 hours on days 1, 9 and 22
Measured: Pupillary resonse to loperamide
Maximum plasma concentration
Measured: up to 75 h after drug administration
Minimum plasma concentration
Measured: up to 75 h after drug administration
Time to reach peak or maximum concentration
Measured: up to 75 h after drug administration
Terminal half life
Measured: up to 75 h after drug administration
Oral clearance
Measured: up to 75 h after drug administration
Area under the plasma concentration time curve
Measured: up to 75 h after drug administration
Number of subjects with adverse events
Measured: up to day 24
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 startJul 2002
- Primary completionJan 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02251119
- Sponsor's protocol ID
- 1182.55
- 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
- The Pharmacodynamic/Pharmacokinetic Interaction of Tipranavir and Ritonavir With Loperamide in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02251119
- Acronym / sponsor ID
- 1182.55
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Jan 2003 (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 the study was to determine if the co-administration of loperamide (LOP) with tipranavir (TPV), ritonavir (RTV), or TPV plus RTV (TPV/r) caused a clinically significant change in the respiratory response to carbon dioxide (CO2), defined as a 10% decrease in the area under the pharmacodynamic effect/time curve or at least a 25% decrease in at least one pharmacodynamic time point.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPV | Experimental | Drug: Tipranavir, Drug: Ritonavir, Drug: LoperamideAdministration of LOP on days 1, 9 and 22 Administration of TPV on days 4-9 Administration of TPV/RTV on days 12-22 |
| RTV | Experimental | Drug: Tipranavir, Drug: Ritonavir, Drug: LoperamideAdministration of LOP on days 1, 9 and 22 Administration of RTV on days 4-9 Administration of TPV/RTV on days 12-22 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Ability and willingness to give written informed consent in accordance with institutional and federal 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 (BMI) between 18 and 35 kg/m2
- Ability to perform a respiratory depression test
- Ability to swallow numerous large capsules without difficulty
Key exclusion criteria (22 listed)
- Female subjects who were of reproductive potential who:
- Participation in another trial with an investigational medicine for 30 days prior to Day 1 (Visit 2)
- Ingestion of any known enzyme-altering drug listed in the protocol 30 days prior to Day 1 (Visit 2)
- Ingestion of grapefruit, grapefruit juice, St. John's Wort, Milk Thistle, Seville oranges and red wine within 14 days prior to Day 1 (Visit 2)
- Ingestion of garlic supplements or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) within 72 hours of PK sampling days (Day 1 [Visit 2], Day 9 [Visit 3], Day 21-22 [Visit 4])
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 | Drug | RTV, TPV |
| Ritonavir | Drug | RTV, TPV |
| Loperamide | Drug | RTV, TPV |
Primary outcome
Maximum decrease in the percentage baseline CO2 response slope
Time frame: up to 6 hours on days 1, 9 and 22
rebreathing test
Zero-to-six hour area under the curve for the percentage baseline CO2 response slope profile
Time frame: up to 6 hours on days 1, 9 and 22
8 secondary outcomes
Change in the ratio between the diameter of the iris and pupil
Time frame: Pupillary resonse to loperamide
Maximum plasma concentration
Time frame: up to 75 h after drug administration
Minimum plasma concentration
Time frame: up to 75 h after drug administration
Time to reach peak or maximum concentration
Time frame: up to 75 h after drug administration
Terminal half life
Time frame: up to 75 h after drug administration
Oral clearance
Time frame: up to 75 h after drug administration
Area under the plasma concentration time curve
Time frame: up to 75 h after drug administration
Number of subjects with adverse events
Time frame: up to day 24
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, Ritonavir and Loperamide 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 16 inclusion and 22 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?
Maximum decrease in the percentage baseline CO2 response slope (time frame: up to 6 hours on days 1, 9 and 22). The study lists 2 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.