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The primary purpose of this study is to evaluate pharmacokinetic comparability of 1x30 mg pegvisomant injection administered as a single 1 mL injection versus 2x15 mg/mL pegvisomant administered as two separate 1 mL injections and to characterize the pharmacokinetics of the new 30 mg strength.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 x 30 mg/mL pegvisomant | Drug | Subcutaneous injection, 30 mg, single dose. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf: Area under the concentration-time profile from time zero extrapolated to infinite time | Area under the concentration-time profile from time zero extrapolated to infinite time | 4, 8, 12 (Day 1), 24, 30, 36 (Day 2), 48, 54, 60 (Day 3), 72, 78, 84 (Day 4), 120 (Day 6), 192 (Day 9), 264 (Day 12), 360 (Day 16) hours postdose |
| AUClast: Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) | Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) | 4, 8, 12 (Day 1), 24, 30, 36 (Day 2), 48, 54, 60 (Day 3), 72, 78, 84 (Day 4), 120 (Day 6), 192 (Day 9), 264 (Day 12), 360 (Day 16) hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum concentration | Maximum concentration | 4, 8, 12 (Day 1), 24, 30, 36 (Day 2), 48, 54, 60 (Day 3), 72, 78, 84 (Day 4), 120 (Day 6), 192 (Day 9), 264 (Day 12), 360 (Day 16) hours postdose |
| Tmax: Time for Cmax |
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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 | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 2 x 15 mg/mL pegvisomant |
| Drug |
Subcutaneous injection, 2 injections of 15 mg, single dose. |
|
Time for Cmax
| 4, 8, 12 (Day 1), 24, 30, 36 (Day 2), 48, 54, 60 (Day 3), 72, 78, 84 (Day 4), 120 (Day 6), 192 (Day 9), 264 (Day 12), 360 (Day 16) hours postdose |
| Half-life:Terminal elimination half-life | Terminal elimination half-life | 4, 8, 12 (Day 1), 24, 30, 36 (Day 2), 48, 54, 60 (Day 3), 72, 78, 84 (Day 4), 120 (Day 6), 192 (Day 9), 264 (Day 12), 360 (Day 16) hours postdose |
| ID | Term |
|---|---|
| C406545 | pegvisomant |
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