Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bioavailability

Intervention / Treatment
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* Drug: pegvisomant
* Drug: pegvisomant
* Drug: pegvisomant
* Drug: pegvisomant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment sequence #1<br>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<br>* 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).<br>* Other names: B2036-PEG;Drug: pegvisomant<br>* 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).<br>* Other names: B2036-PEG;|
| Active Comparator: Treatment sequence #2<br>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<br>* 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).<br>* Other names: B2036-PEG;Drug: pegvisomant<br>* 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).<br>* Other names: B2036-PEG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under the pegvisomant concentration-time curve from time 0 to infinity hours post dose (AUCinf) |  | 16 days | 
| The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast) |  | 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal pegvisomant concentration (Cmax) |  | 16 days | 
| The timepoint at which Cmax is obtained (Tmax) |  | 16 days | 
| Elimination half-life of pegvisomant (as data permit) |  | 16 days | 
| Biomarkers IGF-1 (A few samples will be taken at timepoints around Tmax to observe the pegvisomant effect on IGF-1) |  | 16 days | 
| Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions) |  | 16 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relative bioavailability, pegvisomant