Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT01181973
• Recruitment Status: Completed
• First Posted: August 13, 2010
• Last Update Posted: January 5, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Bioavailability	Drug: pegvisomant	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Study Start Date: October 2010
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: January 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. The area under the pegvisomant concentration-time curve from time 0 to infinity hours post dose (AUCinf) [ Time Frame: 16 days ]
2. The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast) [ Time Frame: 16 days ]

Secondary Outcome Measures :

1. Maximal pegvisomant concentration (Cmax) [ Time Frame: 16 days ]
2. The timepoint at which Cmax is obtained (Tmax) [ Time Frame: 16 days ]
3. Elimination half-life of pegvisomant (as data permit) [ Time Frame: 16 days ]
4. 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 ]
5. Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions) [ Time Frame: 16 days ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• 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

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. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01181973
• Other Study ID Numbers: A6291026
• First Posted: August 13, 2010
• Last Update Posted: January 5, 2012
• Last Verified: January 2012

Keywords provided by Pfizer:

Relative bioavailability; pegvisomant