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Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bioavailability

Intervention: pegvisomant (Drug); pegvisomant (Drug); pegvisomant (Drug); pegvisomant (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

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

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

Primary outcome:

The area under the pegvisomant concentration-time curve from time 0 to infinity hours post dose (AUCinf)

The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast)

Secondary outcome:

Maximal pegvisomant concentration (Cmax)

The timepoint at which Cmax is obtained (Tmax)

Elimination half-life of pegvisomant (as data permit)

Biomarkers IGF-1 (A few samples will be taken at timepoints around Tmax to observe the pegvisomant effect on IGF-1)

Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions)


Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.


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

Locations and Contacts

Pfizer Investigational Site, Singapore 188770, Singapore
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: October 2010
Last updated: January 4, 2012

Page last updated: August 23, 2015

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