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Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181973
First Posted: August 13, 2010
Last Update Posted: January 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]
  • The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast) [ Time Frame: 16 days ]

Secondary Outcome Measures:
  • Maximal pegvisomant concentration (Cmax) [ Time Frame: 16 days ]
  • The timepoint at which Cmax is obtained (Tmax) [ Time Frame: 16 days ]
  • Elimination half-life of pegvisomant (as data permit) [ Time Frame: 16 days ]
  • 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 ]
  • Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions) [ Time Frame: 16 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01181973     History of Changes
Other Study ID Numbers: A6291026
First Submitted: August 12, 2010
First Posted: August 13, 2010
Last Update Posted: January 5, 2012
Last Verified: January 2012

Keywords provided by Pfizer:
Relative bioavailability
pegvisomant