Study Stopped
The study was terminated on 21-Sept-2011 due to the emergent safety concern of sensory symptoms.
A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin
A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects
2 other identifiers
interventional
44
1 country
1
Brief Summary
This study will examine whether a single dose of PF-05230901 is safe and well tolerated when given to healthy volunteers by injection under the skin. An additional objective is to measure the blood concentrations of PF-05230901. Each dose will be tested in a different group of subjects starting from the lowest dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2010
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, 2010
CompletedFirst Submitted
Initial submission to the registry
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
December 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedOctober 12, 2011
October 1, 2011
10 months
November 23, 2010
October 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Incidence and severity of adverse events.
35 days
Incidence and severity of clinical laboratory abnormalities.
35 days
Mean change from baseline in vital signs.
35 days
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters.
35 days
Incidence and severity of findings during the neurological examination.
35 days
Secondary Outcomes (3)
Plasma concentrations
14 days
Anti-drug antibodies
35 days
Appetite and food consumption
13 days
Study Arms (1)
Dose
EXPERIMENTAL6 treated, 3 placebos
Interventions
Single ascending doses of PF-05230901 in separate cohorts of subjects; each cohort consists of 6 subjects treated with PF-05230901 and 3 subjects treated with placebo.
Eligibility Criteria
You may qualify if:
- Healthy subjects
You may not qualify if:
- History of seizures, including childhood seizures.
- History of movement disorders or related neurological conditions.
- History of head trauma associated with loss of consciousness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2010
First Posted
December 17, 2010
Study Start
November 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 12, 2011
Record last verified: 2011-10