Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00864786
• Date of registration: 22/12/2008
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study
• Scientific 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.
• Date of first enrolment: September 2008
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00864786
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Intervention(s)

Drug: PF03635659

Primary Outcome(s)

Pharmacokinetics: Plasma: Cmax, Tmax, AUCinf, AUCt, t½, accumulation ratio, linearity ratio. [Time Frame: 3 Weeks]

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]

Pharmacodynamics: Salivary flow rate [Time Frame: 3 weeks]

Secondary ID(s)

B0431002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors