Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00864786

First received: December 22, 2008

Last updated: March 20, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 22, 2008

Last Updated Date

March 20, 2009

Start Date ^ICMJE

September 2008

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and toleration: Adverse events, vital signs measurements (supine and standing), 12-lead ECGs, spirometry (FEV1, FVC), laboratory safety tests, physical examination, and subject-reported dry mouth assessment. [ Time Frame: 3 Weeks ] [ Designated as safety issue: Yes ]
Pharmacokinetics: Plasma: Cmax, Tmax, AUCinf, AUCτ, t½, accumulation ratio, linearity ratio. [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
Pharmacodynamics: Salivary flow rate [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To investigate the safety and toleration of multiple inhaled does of PF-03635659. [ Time Frame: 3 Weeks ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00864786 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

To investigate the plasma pharmacokinetics of inhaled PF-03635659 following single and multiple dose administration [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
To investigate the pharmacodynamics of inhaled PF-03635659 following multiple dose administration [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

Official Title ^ICMJE

A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalating Study To Investigate The Safety, Toleration, Pharmacokinetics, And Pharmacodynamics Of Multiple Inhaled Doses Of PF-03635659 In Healthy Male Subjects.

Brief Summary

Multiple dose safety and pharmacokinetics in healthy male subjects

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

Drug: PF03635659
Inhaled doses of 200 mcgQD
Drug: PF03635659
Inhaled doses of 600 mcg QD
Drug: PF03635659
Inhaled doses of 1000 mcg QD
Drug: PF03635659
Inhaled dose to be decided based on all available data from previous cohorts. It will run if maximum tolerated dose is not identified from previous cohorts or if a lower dose is required to be investigated.

Study Arm (s)

Experimental: Cohort 1
200 mcg

Intervention: Drug: PF03635659
Experimental: Cohort 2
600 mcg

Intervention: Drug: PF03635659
Experimental: Cohort 3
1000 mcg

Intervention: Drug: PF03635659
Experimental: Cohort 4
Dose to be decided

Intervention: Drug: PF03635659
Experimental: Cohort 5
Dose to be decided

Intervention: Drug: PF03635659

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy male subjects between the ages of 18 and 55 years, inclusive (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).
Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
Any condition possibly affecting drug absorption (eg, gastrectomy).

Gender

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00864786

Other Study ID Numbers ^ICMJE

B0431002

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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