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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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A study to evaluate and compare the PK profiles of abaloparatide-SC 80 μg and abaloparatide-sMTS 300 μg in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women
This study aims to evaluate and compare the pharmacokinetic (PK) profiles of abaloparatide-SC 80 μg injected subcutaneously into the periumbilical region of the abdomen, and abaloparatide-sMTS 300 μg applied to the thigh for 5 minutes in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2) | Experimental | Abaloparatide-SC injection (Period 1) followed by abaloparatide-sMTS application (Period 2). Abaloparatide-SC is a drug-device combination product consisting of abaloparatide, an active synthetic peptide analog of parathyroid hormone related peptide (PTHrP), administered to the periumbilical region via an injection pen. Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. |
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| Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2) | Experimental | Abaloparatide-sMTS (Period 1) application followed by Abaloparatide-SC injection (Period 2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abaloparatide-sMTS | Combination Product | Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| PK Cmax | Maximum observed concentration (Cmax) | Time frame for collection of PK data after each single-dose administration, separated by 48 hours |
| PK AUC1 | Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t) | Time frame for collection of PK data after each single-dose administration, separated by 48 hours |
| PK AUC2 | AUC from time 0 extrapolated to time infinity (AUC 0-∞) | Time frame for collection of PK data after each single-dose administration, separated by 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects with AEs and SAEs | Subjects with treatment-emergent AEs and SAEs. | 10 Days |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace Clinical Pharmacology | Cincinnati | Ohio | 45227 | United States |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000596789 | abaloparatide |
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In each of 2 study periods, subjects received receive either a transdermal patch containing 300 μg abaloparatide for 5 minutes or an injection of abaloparatide SC 80 μg.
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| abaloparatide-SC | Combination Product | Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen |
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| D009750 |
| Nutritional and Metabolic Diseases |