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Single and Multiple Dose Safety, Tolerability, and Pharmacokinetics Study of PF-04805712 in Healthy Volunteers

This study has been terminated.
(B1411001 was terminated after completion of 4 cohorts of the multiple ascending dose phase, as additional data were deemed unnecessary. No safety concerns.)
Information provided by:
Pfizer Identifier:
First received: October 5, 2009
Last updated: November 23, 2010
Last verified: November 2010
To assess the safety and tolerability of escalating single and multiple doses of the compound in healthy volunteers

Condition Intervention Phase
Healthy Volunteers
Drug: PF-04805712
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1 Randomized, Double Blind (3rd Party Open), Placebo Controlled Combined Single And Multiple Dose Safety, Tolerability And Pharmacokinetics Study Of Orally Administered PF-04805712 In Healthy Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety: Adverse events, vital signs measurements, telemetry, 12 lead ECGs, blood and urine safety tests. [ Time Frame: 12 weeks ]
  • Pharmacokinetics: PK parameters will be determined after single dose, fasted and (at one dose) fed, and at steady state (fasted or fed depending on single dose data). [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Pharmacodynamics: Urinary LTE4 [ Time Frame: 12 weeks ]

Enrollment: 61
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04805712 Drug: PF-04805712
ascending single and multiple doses starting at 30 mg


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy males and females of non-childbearing potential.

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00991016

Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00991016     History of Changes
Other Study ID Numbers: B1411001
Study First Received: October 5, 2009
Last Updated: November 23, 2010 processed this record on April 28, 2017