drugset / Trial / NCT01181973

Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

NCT01181973

Phase 1 Completed 14 enrolled Pfizer
RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start
2010-10
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pegvisomant Protein / enzyme biologic 15 mg Subcutaneous
Comparator Pegvisomant Protein / enzyme biologic 30 mg Subcutaneous

Indications

No indication recorded.