A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin
Primary Purpose
Cachexia
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-05230901
PF-05230901
Sponsored by
About this trial
This is an interventional treatment trial for Cachexia focused on measuring First-in-human (FIH), Single Ascending Dose (SAD) Study, TAM-163, PF-05230901, Cachexia
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects
Exclusion Criteria:
- History of seizures, including childhood seizures.
- History of movement disorders or related neurological conditions.
- History of head trauma associated with loss of consciousness.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose
Arm Description
6 treated, 3 placebos
Outcomes
Primary Outcome Measures
Incidence and severity of adverse events.
Incidence and severity of clinical laboratory abnormalities.
Mean change from baseline in vital signs.
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters.
Incidence and severity of findings during the neurological examination.
Secondary Outcome Measures
Plasma concentrations
Anti-drug antibodies
Appetite and food consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01262690
Brief Title
A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin
Official Title
A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated on 21-Sept-2011 due to the emergent safety concern of sensory symptoms.
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia
Keywords
First-in-human (FIH), Single Ascending Dose (SAD) Study, TAM-163, PF-05230901, Cachexia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose
Arm Type
Experimental
Arm Description
6 treated, 3 placebos
Intervention Type
Drug
Intervention Name(s)
PF-05230901
Other Intervention Name(s)
TAM-153
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PF-05230901
Other Intervention Name(s)
TAM-163
Intervention Description
Single dose SC
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events.
Time Frame
35 days
Title
Incidence and severity of clinical laboratory abnormalities.
Time Frame
35 days
Title
Mean change from baseline in vital signs.
Time Frame
35 days
Title
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters.
Time Frame
35 days
Title
Incidence and severity of findings during the neurological examination.
Time Frame
35 days
Secondary Outcome Measure Information:
Title
Plasma concentrations
Time Frame
14 days
Title
Anti-drug antibodies
Time Frame
35 days
Title
Appetite and food consumption
Time Frame
13 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects
Exclusion Criteria:
History of seizures, including childhood seizures.
History of movement disorders or related neurological conditions.
History of head trauma associated with loss of consciousness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2291001&StudyName=A%20Study%20In%20Healthy%20Subjects%20Of%20Single%20Doses%20of%20PF-05230901%20Injected%20Under%20The%20Skin
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin
We'll reach out to this number within 24 hrs