Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756743
• Other study ID #: B0911002
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2008
• Last updated: March 17, 2010
• Start date: September 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Description:

Evaluation of safety and pharmacokinetics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 54 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

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
Placebo capsules q12 hours for 10 days

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		12 days	Yes
Primary	Safety assessments: vital signs, ECG, physical examination, laboratory tests		12 days	Yes
Primary	Pharmacokinetics		12 days	No
Secondary	No secondary outcomes measures.		Timeframe N/A	No

External Links

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