Bioavailability
Conditions
Keywords
Relative bioavailability, pegvisomant
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.
Interventions
DRUGpegvisomant
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).
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Elimination half-life of pegvisomant (as data permit) | 16 days |
| Maximal pegvisomant concentration (Cmax) | 16 days |
| Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions) | 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 |
| The timepoint at which Cmax is obtained (Tmax) | 16 days |
Countries
Singapore
Outcome results
None listed