Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects
- Registration Number
- NCT01181973
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment sequence #2 pegvisomant Two 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 Treatment sequence #1 pegvisomant One 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇬Singapore, Singapore