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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
History of Changes
  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
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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 May 22, 2013