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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990756
• Other study ID #: A9291003
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2009
• Last updated: January 21, 2010
• Start date: November 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-03526299
dry powder for inhalation, 1.396 mg, BID for 14 days
• PF-03526299
dry powder for inhalation, 4 mg, BID for 14 days

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.		17 days	Yes
Secondary	Pharmacokinetic parameters: Plasma Day 1: Cmax, Tmax, AUCtau.		Day 1 - 17	No
Secondary	Plasma Day 7: Cmax, Tmax.		7 Days	No
Secondary	Plasma Day 14: Cmax, Tmax, CL/F, AUCtau, t½, accumulation ratio, time to steady state.		14 Days	No

External Links

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