NCT00990756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 22, 2010

Status Verified

January 1, 2010

Enrollment Period

2 months

First QC Date

October 5, 2009

Last Update Submit

January 21, 2010

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.

    17 days

Secondary Outcomes (3)

  • 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

Study Arms (2)

PF-03526299 1.396 mg

EXPERIMENTAL
Drug: PF-03526299

PF-03526299 4mg

EXPERIMENTAL
Drug: PF-03526299

Interventions

PF-03526299DRUG

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

PF-03526299 1.396 mg

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 5, 2009

First Posted

October 7, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 22, 2010

Record last verified: 2010-01

Locations

SG(1)