HealthyPhase 1NCT00981968
Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects
A Phase 1 study of Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to investigate safety, tolerability and pharmacokinetics of sitaxentan following single and multiple oral administrations of sitaxentan sodium in Japanese healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Nov 2009
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects between the age of 18 and 55 years, inclusive.
- Body Mass Index of 17.5 to 33.5 kg/m2, and a total body weight >45 kg. Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.
Who cannot join
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Glendale, California, 91206
About this study
Official title: An Investigator- And Subjects- Blind Phase 1 Study To Investigate Pharmacokinetics, Safety And Tolerability Of Sitaxentan In Japanese Healthy Subjects Following Single And Multiple Doses And Western Healthy Subjects Following Single Dose
The purpose of this study is to investigate safety, tolerability and pharmacokinetics of sitaxentan following single and multiple oral administrations of sitaxentan sodium in Japanese healthy subjects.
- Conditions
- Healthy
- Being tested
- Sitaxentan sodium/Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitaxentan sodium/PlaceboDrug
Also called Thelin
100 mg and 200 mg, tablet, single and multiple oral doses for 7 days
Sitaxentan sodium/PlaceboDrug
Also called Thelin
100 mg and 200 mg, tablet, single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Japanese Cohort | Experimental | Single and multiple oral doses of sitaxentan sodium or placebo in 12 healthy subjects. Receives: Drug: Sitaxentan sodium/Placebo |
| Western Cohort | Experimental | Single oral dose of sitaxentan sodium in 10 healthy subjects. Receives: Drug: Sitaxentan sodium/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (spontaneous and solicited)
Measured: Day 0 to Day 9 of Period 3 for cohort 1, Day 0 to Day 3 of Period 2 for cohort 2
ECGs, Vital signs, Safety laboratory test
Measured: Screening visit to Day 9 of Period 3 for cohort 1 and Day 3 of Period 2 for cohort 2
Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F
Measured: Day 1 of Periods 1 and 2
Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss
Measured: Days 1 and 7 of Periods 1 and 3
Secondary outcomes (1)
No secondary outcome
Measured: No secondary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionNov 2009
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 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
- NCT00981968
- Sponsor's protocol ID
- B1321046
- Status last verified
- Oct 2010
- First submitted
- 21 Sep 2009
- Last updated
- 15 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator- And Subjects- Blind Phase 1 Study To Investigate Pharmacokinetics, Safety And Tolerability Of Sitaxentan In Japanese Healthy Subjects Following Single And Multiple Doses And Western Healthy Subjects Following Single Dose
- ClinicalTrials.gov ID
- NCT00981968
- Acronym / sponsor ID
- B1321046
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Sep 2009 (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 purpose of this study is to investigate safety, tolerability and pharmacokinetics of sitaxentan following single and multiple oral administrations of sitaxentan sodium in Japanese healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Japanese Cohort | Experimental | Drug: Sitaxentan sodium/PlaceboSingle and multiple oral doses of sitaxentan sodium or placebo in 12 healthy subjects. |
| Western Cohort | Experimental | Drug: Sitaxentan sodium/PlaceboSingle oral dose of sitaxentan sodium in 10 healthy subjects. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female subjects between the age of 18 and 55 years, inclusive.
- Body Mass Index of 17.5 to 33.5 kg/m2, and a total body weight >45 kg. Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.
Key exclusion criteria (1 listed)
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
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 |
|---|---|---|
| Sitaxentan sodium/PlaceboAlso: Thelin100 mg and 200 mg, tablet, single and multiple oral doses for 7 days | Drug | Japanese Cohort |
| Sitaxentan sodium/PlaceboAlso: Thelin100 mg and 200 mg, tablet, single oral dose | Drug | Western Cohort |
Primary outcome
Adverse events (spontaneous and solicited)
Time frame: Day 0 to Day 9 of Period 3 for cohort 1, Day 0 to Day 3 of Period 2 for cohort 2
ECGs, Vital signs, Safety laboratory test
Time frame: Screening visit to Day 9 of Period 3 for cohort 1 and Day 3 of Period 2 for cohort 2
Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F
Time frame: Day 1 of Periods 1 and 2
Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss
Time frame: Days 1 and 7 of Periods 1 and 3
1 secondary outcome
No secondary outcome
Time frame: No secondary outcome
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 15 Oct 2010.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy, run by Pfizer at 1 site in United States.
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 2 inclusion and 1 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 15 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Adverse events (spontaneous and solicited) (time frame: Day 0 to Day 9 of Period 3 for cohort 1, Day 0 to Day 3 of Period 2 for cohort 2). 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 15 Oct 2010; AzTrials last refreshed its copy on 6 Nov 2026.