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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991016
First Posted: October 7, 2009
Last Update Posted: November 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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 (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991016


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00991016     History of Changes
Other Study ID Numbers: B1411001
First Submitted: October 5, 2009
First Posted: October 7, 2009
Last Update Posted: November 24, 2010
Last Verified: November 2010