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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00991016
First received: October 5, 2009
Last updated: November 23, 2010
Last verified: November 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamics: Urinary LTE4 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00991016     History of Changes
Other Study ID Numbers: B1411001
Study First Received: October 5, 2009
Last Updated: November 23, 2010
Health Authority: Singapore: Health Authority and EC

ClinicalTrials.gov processed this record on October 23, 2014