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: September 24, 2014
Last verified: September 2014
  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 ]
    will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

  • ECGs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

  • Blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

  • pulse rate [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

  • Injection siter reaction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The number and percentage of subjects that experienced injection site reactions will be analyzed.

  • number of subjects with adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

  • severity of adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects


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 ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  • 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
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: NCT01753791

Locations
Belgium
Pfizer Clinical Research Unit
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, 2012-003797-13
Study First Received: November 20, 2012
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 19, 2014