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The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.
This study consists of two parts: Part 1 and Part 2. The Part 1 is a single-center, randomized, 2-way crossover study that investigates the pharmacokinetics, safety, and tolerability of teriparatide after a single dose of AK159 (5 levels) and estimates the relative bioavailability of AK159 with subcutaneous teriparatide acetate in healthy post-menopausal women.
The Part 2 is a multiple-center, randomized, double-blind, positive- and placebo-controlled, parallel study that compares the pharmacokinetics, bone makers, safety, and tolerability of teriparatide after a weekly doses of AK159 (4 levels) for 6 weeks with placebo and a weekly doses of subcutaneous teriparatide acetate in healthy post-menopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK159 SD 1 | Experimental | Single administration of AK159 dose level 1 |
|
| AK159 SD 2 | Experimental | Single administration of AK159 dose level 2 |
|
| AK159 SD 3 | Experimental | Single administration of AK159 dose level 3 |
|
| AK159 SD 4 | Experimental | Single administration of AK159 dose level 4 |
|
| MN-10-T SD | Active Comparator | Single administration of teriparatide acetate |
|
| AK159 MD 1 | Experimental | Multiple administration of AK159 dose level 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK159 | Drug | transdermal administration of teriparatide acetate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of teriparatide | up to 6 hours after single and repeated administration | |
| Peak Plasma Concentration (Cmax) of teriparatide | up to 6 hours after single and repeated administration | |
| Number of subjects with adverse events and Incidence of adverse events | up to 7 weeks after the initial administration | |
| Change in bone turnover markers from baseline | up to 7 weeks after the initial administration |
| Measure | Description | Time Frame |
|---|---|---|
| Visual assessment of the application site | up to 7 weeks after the initial administration |
| Measure | Description | Time Frame |
|---|---|---|
| Residual teriparatide in the patch after application | up to 6 weeks after the initial administration |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan | |||||
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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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| AK159 MD 2 |
| Experimental |
Multiple administration of AK159 dose level 2 |
|
| AK159 MD 3 | Experimental | Multiple administration of AK159 dose level 3 |
|
| AK159 MD 4 | Experimental | Multiple administration of AK159 dose level 4 |
|
| MN-10-T MD | Active Comparator | Multiple administration of MN-10-T |
|
| Placebo MD | Placebo Comparator | Multiple administration of placebo AK159 |
|
| MN-10-T | Drug | subcutaneous administration of teriparatide acetate |
|
| Placebo | Drug | Placebo AK159 |
|
| Kumamoto |
| Japan |
| Sumida City | Japan |
| D009750 |
| Nutritional and Metabolic Diseases |