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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
Sponsor:
Information provided by:
Taisho Pharmaceutical Co., Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-04802540 Drug: Placebo Phase 1

Detailed Description:
Evaluation of safety and pharmacokinetics

Study Design
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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
Arms and Interventions
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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


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

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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00756743     History of Changes
Other Study ID Numbers: B0911002
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: March 19, 2010
Last Verified: January 2009

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