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Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00756743
First received: September 19, 2008
Last updated: March 17, 2010
Last verified: January 2009
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
  • Safety assessments: vital signs, ECG, physical examination, laboratory tests [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: 12 days ] [ Designated as safety issue: No ]

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

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

  Eligibility

Ages Eligible for Study:   21 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00756743

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

Additional Information:
No publications provided

Responsible Party: Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00756743     History of Changes
Other Study ID Numbers: B0911002
Study First Received: September 19, 2008
Last Updated: March 17, 2010
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Taisho Pharmaceutical Co., Ltd.:
PF-04802540 multiple dose safety study

ClinicalTrials.gov processed this record on November 24, 2014