Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study

Pfizer

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: PF03635659

Study type: Interventional

Funder types: Industry

Identifiers

NCT00864786

B0431002

Details and patient eligibility

About

Multiple dose safety and pharmacokinetics in healthy male subjects

Enrollment: 50 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 5 patient groups

Cohort 1

Experimental group

Description:

200 mcg

Treatment:

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Cohort 2

Experimental group

Description:

600 mcg

Treatment:

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Cohort 3

Experimental group

Description:

1000 mcg

Treatment:

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Cohort 4

Experimental group

Description:

Dose to be decided

Treatment:

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Cohort 5

Experimental group

Description:

Dose to be decided

Treatment:

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659

Drug: PF03635659