A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01415102
First received: September 29, 2010
Last updated: August 12, 2011
Last verified: August 2011
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Purpose
The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of PF-05212372.
| Condition | Intervention | Phase |
|---|---|---|
|
Phase 1 Single Dose Safety Toleration Pharmacokinetics |
Drug: PF-05212372 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover 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 Single Inhaled Doses Of Pf-05212372 In Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
- Plasma pharmacokinetics [ Time Frame: up to 72 hours post dose ] [ Designated as safety issue: No ]
- Urine pharmacokinetics [ Time Frame: up to 24 hours post dose ] [ Designated as safety issue: No ]
- Urine Pharmacodynamics [ Time Frame: up to 24 hours post dose ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | September 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
Subjects will be assigned to receive either PF-05212372 or placebo in each period
|
Drug: PF-05212372
Inhaled. Dose Level 1: 50 ug
Drug: PF-05212372
Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: Placebo
Inhaled
|
|
Experimental: Cohort 2
Subjects will be assigned to receive either PF-05212372 or placebo in each period
|
Drug: PF-05212372
Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: Placebo
Inhaled
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
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.
- Treatment with an investigational drug within the past 30 days (or local regulations) or 5 half-lives preceding the first dose of study medication.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01415102 History of Changes |
| Other Study ID Numbers: | B2031001 |
| Study First Received: | September 29, 2010 |
| Last Updated: | August 12, 2011 |
| Health Authority: | Belgium: FAMHP(Federal Agency for Medicines and Healthy Products) |
ClinicalTrials.gov processed this record on June 17, 2013