Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT00756743 |
Recruitment Status :
Completed
First Posted : September 22, 2008
Last Update Posted : March 19, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: PF-04802540 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
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 |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | January 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: PF-04802540 |
Drug: PF-04802540
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 |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo capsules q12 hours for 10 days |
- Adverse events [ Time Frame: 12 days ]
- Safety assessments: vital signs, ECG, physical examination, laboratory tests [ Time Frame: 12 days ]
- Pharmacokinetics [ Time Frame: 12 days ]
- No secondary outcomes measures. [ Time Frame: Timeframe N/A ]

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Ages Eligible for Study: | 21 Years to 54 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Use of prescription or nonprescription drugs
- Any condition possibly affecting drug absorption

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756743
Singapore | |
Pfizer Investigational Site | |
Singapore, Singapore, 188770 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Taisho Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00756743 |
Other Study ID Numbers: |
B0911002 |
First Posted: | September 22, 2008 Key Record Dates |
Last Update Posted: | March 19, 2010 |
Last Verified: | January 2009 |
PF-04802540 multiple dose safety study |