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CompletedNCT00864786Updated Mar 23, 2009

Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

A Phase 1 interventional study of PF03635659 and PF03635659 in Chronic Obstructive Pulmonary Disease, sponsored by Pfizer. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-03-23.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

Multiple dose safety and pharmacokinetics in healthy male subjects

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • Multiple dose safety and pharmacokinetics study
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's planned enrollment of 50 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    200 mcg

    Drug: PF03635659

  • Experimental
    Cohort 2

    600 mcg

    Drug: PF03635659

  • Experimental
    Cohort 3

    1000 mcg

    Drug: PF03635659

  • Experimental
    Cohort 4

    Dose to be decided

    Drug: PF03635659

  • Experimental
    Cohort 5

    Dose to be decided

    Drug: PF03635659

Interventions

  • DrugPF03635659

    Inhaled doses of 200 mcgQD

  • DrugPF03635659

    Inhaled doses of 600 mcg QD

  • DrugPF03635659

    Inhaled doses of 1000 mcg QD

  • DrugPF03635659

    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.

  • DrugPF03635659

    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.

06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: 3 Weeks

  3. Pharmacodynamics: Salivary flow rate

    Time frame: 3 weeks

07

Study locations

1 site
  • Pfizer Investigational Site
    Bruxelles, 1070, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00864786
Lead sponsor
Pfizer
First posted
Mar 19, 2009
Start date
Sep 2008
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Mar 23, 2009

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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