NCT00756743
Completed
Phase 1
A Phase I Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04802540 After Multiple Oral Dose Administration To Healthy Adult Volunteers
Overview
- Phase
- Phase 1
- Intervention
- PF-04802540
- Conditions
- Healthy
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Detailed Description
Evaluation of safety and pharmacokinetics
Investigators
Eligibility 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
Arms & Interventions
PF-04802540
Intervention: PF-04802540
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Pharmacokinetics
Time Frame: 12 days
Adverse events
Time Frame: 12 days
Safety assessments: vital signs, ECG, physical examination, laboratory tests
Time Frame: 12 days
Secondary Outcomes
- No secondary outcomes measures.(Timeframe N/A)
Study Sites (1)
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