Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults
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
2 other identifiers
interventional
32
1 country
1
Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06473871 in normal healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Nov 2012
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 20, 2012
CompletedFirst Posted
Study publicly available on registry
December 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedSeptember 26, 2014
September 1, 2014
7 months
November 20, 2012
September 24, 2014
Conditions
Outcome Measures
Primary Outcomes (7)
Incidence of Adverse events
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
6 weeks
ECGs
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
6 weeks
Blood pressure
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
6 weeks
pulse rate
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
6 weeks
Injection siter reaction
The number and percentage of subjects that experienced injection site reactions will be analyzed.
6 weeks
number of subjects with adverse events
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
6 weeks
severity of adverse events
will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects
6 weeks
Secondary Outcomes (3)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
6 weeks
Area under the Concentration-Time Curve (AUC)
6 weeks
Maximum Observed Plasma Concentration (Cmax)
6 weeks
Study Arms (4)
Cohort 1
EXPERIMENTALCohort 2
EXPERIMENTALCohort 3
EXPERIMENTALCohort 4
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy male and/or females between the ages of 18 and 55 years inclusive
You may not qualify if:
- Currently pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Clinical Research Unit
Brussels, B-1070, Belgium
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2012
First Posted
December 20, 2012
Study Start
November 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
September 26, 2014
Record last verified: 2014-09