Pulmonary Arterial HypertensionPhase 1NCT01251848
Drug Interaction Between Ritonavir And Sitaxsentan
A Phase 1 study testing Sitaxentan, Ritonavir and Sitaxsentan in people with Pulmonary Arterial Hypertension, run by Pfizer.
Trial summary
The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Sitaxentan, Ritonavir and Sitaxsentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Feb 2011
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects and/or women of non-child bearing potential.
- Subjects (because of teratogenic risk of sitaxsentan) between the ages of 21 and 55 years, inclusive.
- Signed informed consent.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- History of significant alcohol and drug use.
- Has hepatic dysfunction.
About this study
Official title: A Phase 1, Open Label, Randomized, Multiple Dose Study To Assess The Two-Way Drug Interaction Between Sitaxsentan And Low Dose Ritonavir In Healthy Subjects
The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Sitaxentan, Ritonavir, Sitaxsentan
- Keywords
- Sitaxentan, ritonavir, drug interaction, pharmacokinetics
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitaxentanDrug
Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days.
RitonavirDrug
Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days (morning dose only on Day 5).
SitaxsentanDrug
Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days
RitonavirDrug
Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Not described Receives: Drug: Sitaxentan |
| Treatment B | Active comparator | Not described Receives: Drug: Ritonavir |
| Treatment C | Experimental | Not described Receives: Drug: Sitaxsentan; Drug: Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
Measured: 24 hours
The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
Measured: 24 hours
The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
Measured: 24 hours
The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251848
- Sponsor's protocol ID
- B1321061
- Status last verified
- Mar 2015
- First submitted
- 1 Dec 2010
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Randomized, Multiple Dose Study To Assess The Two-Way Drug Interaction Between Sitaxsentan And Low Dose Ritonavir In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01251848
- Acronym / sponsor ID
- B1321061
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Sitaxentan, ritonavir, drug interaction, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 2 Dec 2010 (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 study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: Sitaxentan |
| Treatment B | Active comparator | Drug: Ritonavir |
| Treatment C | Experimental | Drug: Sitaxsentan, Drug: Ritonavir |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects and/or women of non-child bearing potential.
- Subjects (because of teratogenic risk of sitaxsentan) between the ages of 21 and 55 years, inclusive.
- Signed informed consent.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- History of significant alcohol and drug use.
- Has hepatic dysfunction.
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 |
|---|---|---|
| SitaxentanSitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days. | Drug | Treatment A |
| RitonavirRitonavir Capsule, 100 mg, q12h (twice daily) for 5 days (morning dose only on Day 5). | Drug | Treatment B |
| SitaxsentanSitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days | Drug | Treatment C |
| RitonavirRitonavir Capsule, 100 mg, q12h (twice daily) for 5 days | Drug | Treatment C |
Primary outcome
The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
Time frame: 24 hours
The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
Time frame: 24 hours
The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
Time frame: 24 hours
The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sitaxentan, Ritonavir and Sitaxsentan in people with Pulmonary Arterial Hypertension, run by Pfizer.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 5 Mar 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone. (time frame: 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 5 Mar 2015.