Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

Bioavailability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181973
• Other study ID #: A6291026
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2010
• Last updated: January 4, 2012
• Start date: October 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bioavailability

Intervention

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).
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The area under the pegvisomant concentration-time curve from time 0 to infinity hours post dose (AUCinf)		16 days	No
Primary	The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast)		16 days	No
Secondary	Maximal pegvisomant concentration (Cmax)		16 days	No
Secondary	The timepoint at which Cmax is obtained (Tmax)		16 days	No
Secondary	Elimination half-life of pegvisomant (as data permit)		16 days	No
Secondary	Biomarkers IGF-1 (A few samples will be taken at timepoints around Tmax to observe the pegvisomant effect on IGF-1)		16 days	No
Secondary	Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions)		16 days	No

External Links

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