Healthy
Conditions
Keywords
PF-04802540 multiple dose safety study
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
Interventions
DRUGPF-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
DRUGPlacebo
Placebo capsules q12 hours for 10 days
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 54 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | 12 days |
| Safety assessments: vital signs, ECG, physical examination, laboratory tests | 12 days |
| Pharmacokinetics | 12 days |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes measures. | Timeframe N/A |
Countries
Singapore
Outcome results
None listed