Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bioavailability
Intervention: pegvisomant (Drug); pegvisomant (Drug); pegvisomant (Drug); pegvisomant (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: The area under the pegvisomant concentration-time curve from time 0 to infinity hours post dose (AUCinf)The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast)
Secondary outcome: Maximal pegvisomant concentration (Cmax)The timepoint at which Cmax is obtained (Tmax) Elimination half-life of pegvisomant (as data permit) Biomarkers IGF-1 (A few samples will be taken at timepoints around Tmax to observe the pegvisomant effect on IGF-1) Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions)
Eligibility
Minimum age: 21 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy males or females between the ages of 21 and 55 years
Exclusion Criteria:
- Positive urine drug screen
- Excessive use of alcohol or nicotine-containing products
- Pregnant or nursing females
Locations and Contacts
Pfizer Investigational Site, Singapore 188770, Singapore
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2010
Last updated: January 4, 2012
|
