A Single Dose Study Of PF-06291874 In Healthy Adult Subjects

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01499017
First received: November 14, 2011
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.


Condition Intervention Phase
Healthy
Drug: PF-06291874 or placebo
Drug: PF-06291874 or Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo-Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of PF-06291874 After Administration Under Fasted And Fed Conditions In Healthy Adult Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability data: number of subjects with adverse events and Laboratory Test Values of Potential Clinical Importance, Changes from baseline in pulse rate, blood pressure and Electrocardiogram (ECG) measurements over 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: Yes ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] - Fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) fasted - 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) -fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
  • Apparent Oral Clearance (CL/F) fed 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]
  • Apparent Volume of Distribution (V/F) fed 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs [ Time Frame: 2 days/dose group ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A
Each subjects in Cohort A will receive 3 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-4.
Drug: PF-06291874 or placebo
PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 3 mg to 100 mg. Correspondingly, placebo doses will be administered as suspension.
Other Name: Not specified
Experimental: Cohort B
Each subjects in Cohort B will receive 2 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-06291874 will be administered in Period 4 in the fed state.
Drug: PF-06291874 or Placebo
PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 300 mg to 650 mg. Correspondingly, placebo doses will be administered as suspension.
Other Name: Not Specified

Detailed Description:

The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers. The trial was terminated on Jan 9, 2012, due to undesired pharmacokinetic properties. The decision to terminate the trial was not based on any safety or efficacy concerns.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects of non childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499017

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01499017     History of Changes
Other Study ID Numbers: B4801001
Study First Received: November 14, 2011
Last Updated: January 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Single Ascending Dose Study in healthy subjects

ClinicalTrials.gov processed this record on April 21, 2014