HealthyPhase 1NCT00756743
Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers
A Phase 1 study testing PF-04802540 in people with Healthy, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Singapore.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to healthy adult subjects. Read more about this study
- Who is it for?
- Ages 21 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-04802540
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2008to Jan 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 21 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females of non-childbearing capacity aged 21 to 55 years inclusive at screening.
- Body mass index in the range of 18 to 30 kg/m2 and body weight>45 kg.
- Healthy as determined by the investigator on the basis of screening evaluation.
Who cannot join
- Use of prescription or nonprescription drugs
- Any condition possibly affecting drug absorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04802540 After Multiple Oral Dose Administration To Healthy Adult Volunteers
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.
Read the detailed description
Evaluation of safety and pharmacokinetics
- Conditions
- Healthy
- Being tested
- PF-04802540, Placebo
- Keywords
- PF-04802540 multiple dose safety study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04802540Drug
Multiple ascending doses for 10 days; planned doses include 5, 10 and 15 mg capsules q12 hours, doses may be adjusted based on accumulating data
PlaceboDrug
Placebo capsules q12 hours for 10 days
| Study group | Role | What they receive |
|---|---|---|
| PF-04802540 | Experimental | Not described Receives: Drug: PF-04802540 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 12 days
Safety assessments: vital signs, ECG, physical examination, laboratory tests
Measured: 12 days
Pharmacokinetics
Measured: 12 days
Secondary outcomes (1)
No secondary outcomes measures.
Measured: Timeframe N/A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionJan 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.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756743
- Sponsor's protocol ID
- B0911002
- Status last verified
- Jan 2009
- First submitted
- 19 Sep 2008
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04802540 After Multiple Oral Dose Administration To Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00756743
- Acronym / sponsor ID
- B0911002
- Conditions
- Healthy
- Keywords
- PF-04802540 multiple dose safety study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Sep 2008 (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 evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.
Detailed description
Evaluation of safety and pharmacokinetics
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04802540 | Experimental | Drug: PF-04802540 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males or females of non-childbearing capacity aged 21 to 55 years inclusive at screening.
- Body mass index in the range of 18 to 30 kg/m2 and body weight>45 kg.
- Healthy as determined by the investigator on the basis of screening evaluation.
Key exclusion criteria (2 listed)
- Use of prescription or nonprescription drugs
- Any condition possibly affecting drug absorption
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 |
|---|---|---|
| PF-04802540Multiple ascending doses for 10 days; planned doses include 5, 10 and 15 mg capsules q12 hours, doses may be adjusted based on accumulating data | Drug | PF-04802540 |
| PlaceboPlacebo capsules q12 hours for 10 days | Drug | Placebo |
Primary outcome
Adverse events
Time frame: 12 days
Safety assessments: vital signs, ECG, physical examination, laboratory tests
Time frame: 12 days
Pharmacokinetics
Time frame: 12 days
1 secondary outcome
No secondary outcomes measures.
Time frame: Timeframe N/A
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 19 Mar 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 testing PF-04802540 in people with Healthy, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Singapore.
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 2 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 19 Mar 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 Singapore. 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. Some participants in this study may receive a placebo. 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 (time frame: 12 days). The study lists 3 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 19 Mar 2010.