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Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

Last updated on March 22, 2018

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Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bioavailability
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy males or females between the ages of 21 and 55 years

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Positive urine drug screen

- Excessive use of alcohol or nicotine-containing products

- Pregnant or nursing females

NCT01181973
Pfizer
Completed
Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

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Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Bioavailability
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
January 2011
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01181973
A6291026
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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