A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: PF-03526299
- Registration Number
- NCT00990756
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to investigate safety and toleration of multiple inhaled doses as well as the time course of PF-03526299 concentration in the blood following dosing by dry powder inhaler.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Healthy male subjects and females of non-childbearing potential between the ages of 21 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).
- Subjects who had a normal chest X-ray in the previous 6 months prior to Screening
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-03526299 1.396 mg PF-03526299 - PF-03526299 4mg PF-03526299 -
- Primary Outcome Measures
Name Time Method Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. 17 days
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters: Plasma Day 1: Cmax, Tmax, AUCτau. Day 1 - 17 Plasma Day 7: Cmax, Tmax. 7 Days Plasma Day 14: Cmax, Tmax, CL/F, AUCτau, t½, accumulation ratio, time to steady state. 14 Days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇬Singapore, Singapore