A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00990756
First received: October 5, 2009
Last updated: January 21, 2010
Last verified: January 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-03526299 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03526299 In Healthy Male Subjects |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. [ Time Frame: 17 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetic parameters: Plasma Day 1: Cmax, Tmax, AUCτau. [ Time Frame: Day 1 - 17 ] [ Designated as safety issue: No ]
- Plasma Day 7: Cmax, Tmax. [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
- Plasma Day 14: Cmax, Tmax, CL/F, AUCτau, t½, accumulation ratio, time to steady state. [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | November 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-03526299 1.396 mg |
Drug: PF-03526299
dry powder for inhalation, 1.396 mg, BID for 14 days
|
| Experimental: PF-03526299 4mg |
Drug: PF-03526299
dry powder for inhalation, 4 mg, BID for 14 days
|
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00990756 History of Changes |
| Other Study ID Numbers: | A9291003 |
| Study First Received: | October 5, 2009 |
| Last Updated: | January 21, 2010 |
| Health Authority: | Singapore: Health Sciences Authority |
ClinicalTrials.gov processed this record on May 16, 2013