NCT00864786

Brief Summary

Multiple dose safety and pharmacokinetics in healthy male subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
Last Updated

March 23, 2009

Status Verified

March 1, 2009

Enrollment Period

6 months

First QC Date

December 22, 2008

Last Update Submit

March 20, 2009

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Multiple dose safety and pharmacokinetics study

Outcome Measures

Primary Outcomes (3)

  • 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.

    3 Weeks

  • Pharmacokinetics: Plasma: Cmax, Tmax, AUCinf, AUCτ, t½, accumulation ratio, linearity ratio.

    3 Weeks

  • Pharmacodynamics: Salivary flow rate

    3 weeks

Study Arms (5)

Cohort 1

EXPERIMENTAL

200 mcg

Drug: PF03635659

Cohort 2

EXPERIMENTAL

600 mcg

Drug: PF03635659

Cohort 3

EXPERIMENTAL

1000 mcg

Drug: PF03635659

Cohort 4

EXPERIMENTAL

Dose to be decided

Drug: PF03635659

Cohort 5

EXPERIMENTAL

Dose to be decided

Drug: PF03635659

Interventions

PF03635659DRUG

Inhaled doses of 200 mcgQD

Cohort 1

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2008

First Posted

March 19, 2009

Study Start

September 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 23, 2009

Record last verified: 2009-03

Locations

BE(1)