Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01753791
First received: November 20, 2012
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06473871 in normal healthy adults.


Condition Intervention Phase
Healthy
Drug: 80 mg PF-06473871
Drug: 160 mg PF-06473871
Drug: 320 mg PF-06473871
Drug: 480 mg PF-06473871
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1, Dose Expansion Of A Within-Cohort, Randomized, Double-Blind, Third-Party Open, Placebo-Controlled, Single-And Multiple-Dose Escalation Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of Adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • ECGs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • pulse rate [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Injection siter reaction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • number of subjects with adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • severity of adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: 80 mg PF-06473871
80 mg of PF-06473871 or placebo
Experimental: Cohort 2 Drug: 160 mg PF-06473871
160 mg of PF-06473871 or placebo
Experimental: Cohort 3 Drug: 320 mg PF-06473871
320 mg of PF-06473871 or placebo
Experimental: Cohort 4 Drug: 480 mg PF-06473871
480 mg of PF-06473871 or placebo

  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 females between the ages of 18 and 55 years inclusive

Exclusion Criteria:

  • Currently pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753791

Locations
Belgium
Pfizer Investigational Site
Brussels, Belgium, B-1070
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: NCT01753791     History of Changes
Other Study ID Numbers: B5301002
Study First Received: November 20, 2012
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 14, 2014