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Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers

This study has been completed.
Information provided by:
Taisho Pharmaceutical Co., Ltd. Identifier:
First received: September 19, 2008
Last updated: March 17, 2010
Last verified: January 2009
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.

Condition Intervention Phase
Healthy Drug: PF-04802540 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Taisho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 12 days ]
  • Safety assessments: vital signs, ECG, physical examination, laboratory tests [ Time Frame: 12 days ]
  • Pharmacokinetics [ Time Frame: 12 days ]

Secondary Outcome Measures:
  • No secondary outcomes measures. [ Time Frame: Timeframe N/A ]

Enrollment: 40
Study Start Date: September 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Evaluation of safety and pharmacokinetics

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00756743

Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Taisho Pharmaceutical Co., Ltd.
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Taisho Pharmaceutical Co., Ltd. Identifier: NCT00756743     History of Changes
Other Study ID Numbers: B0911002
Study First Received: September 19, 2008
Last Updated: March 17, 2010

Keywords provided by Taisho Pharmaceutical Co., Ltd.:
PF-04802540 multiple dose safety study processed this record on September 21, 2017