Back to resultsMultiple Dose Healthy Volunteer Safety Pharmacokinetics Study
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
PF03635659
PF03635659
PF03635659
PF03635659
PF03635659
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Multiple dose safety and pharmacokinetics study
Eligibility Criteria
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).
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Arm Description
200 mcg
600 mcg
1000 mcg
Dose to be decided
Dose to be decided
Outcomes
Primary Outcome Measures
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.
Pharmacokinetics: Plasma: Cmax, Tmax, AUCinf, AUCτ, t½, accumulation ratio, linearity ratio.
Pharmacodynamics: Salivary flow rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00864786
Brief Title
Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Multiple dose safety and pharmacokinetics in healthy male subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Multiple dose safety and pharmacokinetics study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
200 mcg
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
600 mcg
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
1000 mcg
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Dose to be decided
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Dose to be decided
Intervention Type
Drug
Intervention Name(s)
PF03635659
Intervention Description
Inhaled doses of 200 mcgQD
Intervention Type
Drug
Intervention Name(s)
PF03635659
Intervention Description
Inhaled doses of 600 mcg QD
Intervention Type
Drug
Intervention Name(s)
PF03635659
Intervention Description
Inhaled doses of 1000 mcg QD
Intervention Type
Drug
Intervention Name(s)
PF03635659
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PF03635659
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Pharmacokinetics: Plasma: Cmax, Tmax, AUCinf, AUCτ, t½, accumulation ratio, linearity ratio.
Time Frame
3 Weeks
Title
Pharmacodynamics: Salivary flow rate
Time Frame
3 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0431002&StudyName=Multiple%20dose%20healthy%20volunteer%20safety%20pharmacokinetics%20study
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study
We'll reach out to this number within 24 hrs