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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence #1 | Active Comparator | 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 |
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| Treatment sequence #2 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegvisomant | Drug | 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). |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | 188770 | Singapore |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C406545 | pegvisomant |
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|
| pegvisomant | Drug | 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 | Drug | 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 | Drug | 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). |
|
|
| 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 |