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
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 April 17, 2014