Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01181973
First received: August 12, 2010
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Bioavailability
Drug: pegvisomant
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The area under the pegvisomant concentration-time curve from time 0 to infinity hours post dose (AUCinf) [ Time Frame: 16 days ] [ Designated as safety issue: No ]
  • The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast) [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximal pegvisomant concentration (Cmax) [ Time Frame: 16 days ] [ Designated as safety issue: No ]
  • The timepoint at which Cmax is obtained (Tmax) [ Time Frame: 16 days ] [ Designated as safety issue: No ]
  • Elimination half-life of pegvisomant (as data permit) [ Time Frame: 16 days ] [ Designated as safety issue: No ]
  • Biomarkers IGF-1 (A few samples will be taken at timepoints around Tmax to observe the pegvisomant effect on IGF-1) [ Time Frame: 16 days ] [ Designated as safety issue: No ]
  • Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions) [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: October 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 #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
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
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

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181973

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01181973     History of Changes
Other Study ID Numbers: A6291026
Study First Received: August 12, 2010
Last Updated: January 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Relative bioavailability
pegvisomant

ClinicalTrials.gov processed this record on October 21, 2014