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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01181973
Other study ID # A6291026
Secondary ID
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


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
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