Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

• Drug: pegvisomant
  
  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).
  Other Name: B2036-PEG
• Drug: pegvisomant
  
  Two 1-mL subcutaneous injections at 15 mg/mL each. Two 15-mg vials are supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).
  Other Name: B2036-PEG

• Active Comparator: Treatment sequence #1
  
  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
  Interventions:
  

  • Drug: pegvisomant
  • Drug: pegvisomant
• Active Comparator: Treatment sequence #2
  
  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
  Interventions:
  

  • Drug: pegvisomant
  • Drug: pegvisomant

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