Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects
An Open-label, Randomized, Phase 1, Single-Dose Crossover Study to Evaluate Safety, Tolerability and Relative Bioavailability of Pegvisomant 1 X 30 Mg Vs 2 X 15 Mg Subcutaneously Administered in Healthy Subjects
1 other identifier
interventional
14
1 country
1
Brief Summary
The hypothesis to be tested is that the bioavailability of the new 30-mg vial is similar to that of the current approved 15 -mg vials. In addition, the SC injection using the new 30-mg vial is safe and well-tolerated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2010
Shorter than P25 for phase_1
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
First Submitted
Initial submission to the registry
August 12, 2010
CompletedFirst Posted
Study publicly available on registry
August 13, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedJanuary 5, 2012
January 1, 2012
3 months
August 12, 2010
January 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The area under the pegvisomant concentration-time curve from time 0 to infinity hours post dose (AUCinf)
16 days
The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast)
16 days
Secondary Outcomes (5)
Maximal pegvisomant concentration (Cmax)
16 days
The timepoint at which Cmax is obtained (Tmax)
16 days
Elimination half-life of pegvisomant (as data permit)
16 days
Biomarkers IGF-1 (A few samples will be taken at timepoints around Tmax to observe the pegvisomant effect on IGF-1)
16 days
Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions)
16 days
Study Arms (2)
Treatment sequence #1
ACTIVE COMPARATOROne 1-mL subcutaneous injection at 30 mg/mL in Period 1 and two 1-mL subcutaneous injections at 15 mg/mL each in Period 2
Treatment sequence #2
ACTIVE COMPARATORTwo 1-mL subcutaneous injections at 15 mg/mL each in Period 1 and one 1-mL SC injection at 30 mg/mL in Period 2
Interventions
One 1-mL subcutaneous injection at 30 mg/mL. A 30-mg vial is supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).
Eligibility Criteria
You may qualify if:
- Healthy males or females between the ages of 21 and 55 years
You may not qualify if:
- Positive urine drug screen
- Excessive use of alcohol or nicotine-containing products
- Pregnant or nursing females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Singapore, 188770, Singapore
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2010
First Posted
August 13, 2010
Study Start
October 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
January 5, 2012
Record last verified: 2012-01