NCT00117949

Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486 CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both studies were to guide dose selection for phase III. In addition, safety and tolerance data were generated.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Degarelix	One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
DRUG	Degarelix	One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
DRUG	Degarelix	One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
DRUG	Degarelix	One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.

Timeline

• Start date: 2002-04-01
• Primary completion: 2004-01-01
• Completion: 2004-01-01
• First posted: 2005-07-11
• Last updated: 2011-05-23
• Results posted: 2009-06-05

Locations

12 sites across 1 country: United States