Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects - Full Text View

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 Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: 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:

Drug Information available for: Pegvisomant

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast) [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximal pegvisomant concentration (Cmax) [ Time Frame: 16 days ] [ Designated as safety issue: No ]
The timepoint at which Cmax is obtained (Tmax) [ Time Frame: 16 days ] [ Designated as safety issue: No ]
Elimination half-life of pegvisomant (as data permit) [ Time Frame: 16 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions) [ Time Frame: 16 days ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01181973 History of Changes
Other Study ID Numbers:	A6291026
Study First Received:	August 12, 2010
Last Updated:	January 4, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Relative bioavailability
pegvisomant

ClinicalTrials.gov processed this record on June 17, 2013