NCT01186757

Brief Summary

Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2010

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

Study Start

First participant enrolled

August 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 12, 2011

Status Verified

January 1, 2011

Enrollment Period

5 months

First QC Date

August 11, 2010

Last Update Submit

January 11, 2011

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCtau, t½, accumulation ratio (Rac, Rss, Rac,Cmax).

    17 days

Secondary Outcomes (1)

  • Safety and toleration as measured by adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.

    28 Days

Study Arms (4)

PF-03715455 1.6mg BID

ACTIVE COMPARATOR
Drug: PF-03715455

PF-03715455 4 mg BID

ACTIVE COMPARATOR
Drug: PF-03715455

PF-03715455 10 mg BID

ACTIVE COMPARATOR
Drug: PF-03715455

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-03715455DRUG

PF-03715455 1.6 mg BID

PF-03715455 1.6mg BID
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • Standard healthy volunteer criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

MeSH Terms

Interventions

N-(1-(3-chloro-4-hydroxyphenyl)-3-(1,1-dimethylethyl)-1H-pyrazol-5-yl)-N'-((2-((3-(2-((2-hydroxyethyl)thio)phenyl)-1,2,4-triazolo(4,3-a)pyridin-6-yl)thio)phenyl)methyl)-urea

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 23, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 12, 2011

Record last verified: 2011-01

Locations

SG(1)