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 Intervention Model: Crossover Assignment Masking: Double Blind (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

Eligibility


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

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:

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
Study First Received:	September 19, 2008
Last Updated:	March 17, 2010

Keywords provided by Taisho Pharmaceutical Co., Ltd.:


PF-04802540 multiple dose safety study

ClinicalTrials.gov processed this record on July 21, 2017

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