Bioavailability Clinical Trial
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
Verified date | January 2012 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Singapore | Pfizer Investigational Site | Singapore |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The area under the pegvisomant concentration-time curve from time 0 to infinity hours post dose (AUCinf) | 16 days | No | |
Primary | The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast) | 16 days | No | |
Secondary | Maximal pegvisomant concentration (Cmax) | 16 days | No | |
Secondary | The timepoint at which Cmax is obtained (Tmax) | 16 days | No | |
Secondary | Elimination half-life of pegvisomant (as data permit) | 16 days | No | |
Secondary | Biomarkers IGF-1 (A few samples will be taken at timepoints around Tmax to observe the pegvisomant effect on IGF-1) | 16 days | No | |
Secondary | Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions) | 16 days | No |
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