A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult Volunteers

A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03526299 In Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00990756

Enrollment

Registered

2009-10-07

Start date

2009-11-30

Completion date

2010-01-31

Last updated

2010-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The purpose of this study is to investigate safety and toleration of multiple inhaled doses as well as the time course of PF-03526299 concentration in the blood following dosing by dry powder inhaler.

Interventions

DRUGPF-03526299

dry powder for inhalation, 1.396 mg, BID for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male subjects and females of non-childbearing potential between the ages of 21 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs). * Subjects who had a normal chest X-ray in the previous 6 months prior to Screening

Exclusion criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * A positive urine drug screen. * History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.

Design outcomes

Primary

Measure	Time frame
Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.	17 days

Secondary

Measure	Time frame
Pharmacokinetic parameters: Plasma Day 1: Cmax, Tmax, AUCτau.	Day 1 - 17
Plasma Day 7: Cmax, Tmax.	7 Days
Plasma Day 14: Cmax, Tmax, CL/F, AUCτau, t½, accumulation ratio, time to steady state.	14 Days

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026