Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects
A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects
1 other identifier
interventional
30
1 country
1
Brief Summary
The study is designed to test safety tolerability and PK of single oral ascending doses of PF-06305591,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 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
December 5, 2012
CompletedFirst Posted
Study publicly available on registry
December 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 23, 2013
May 1, 2013
6 months
December 5, 2012
May 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
72 hr
Secondary Outcomes (1)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
72 hr
Study Arms (3)
Cohort 1
EXPERIMENTALSingle ascending oral doses in fasted conditions
Cohort 2
EXPERIMENTALSingle ascending oral doses in fasted conditions
Cohort 3
EXPERIMENTALSingle ascending oral doses in fed conditions
Interventions
Eligibility Criteria
You may qualify if:
- healthy young subjects
- aged 18-55
You may not qualify if:
- 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 the time of dosing).
- Pregnant or nursing females; females of childbearing potential.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
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
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2012
First Posted
December 12, 2012
Study Start
November 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
May 23, 2013
Record last verified: 2013-05