Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.
This study consists of Part 1 and Part 2. <Part 1> Part 1 will be conducted according to a single-centre, randomized, single-dose, 3-period, 5-treatment alternating crossover design in two groups of healthy post-menopausal women The pharmacokinetics, safety, and tolerability of a single dose of AK159 (4 levels) will be investigated versus teriparatide acetate for injection as a control.
<Part 2> Part 2 will be conducted according to a multiple-centre, randomized, double-blind, placebo-controlled, repeated dose parallel design of healthy post-menopausal women The pharmacokinetics, safety, and tolerability of AK159 (4 levels) for 8 weeks will be investigated versus teriparatide acetate for injection and placebo as controls. Pharmacokinetics, safety, and tolerability following long-term application will also be investigated.
Not provided
Not provided
Not provided
Not provided
| 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 MN-10-T |
|
| 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 Participants with Adverse Events, Vital signs, ECG parameters, and 24-hour ECG holter recording (for Part 2 of the study). | up to 24 hours after single and repeated administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in bone turnover markers within 24 hrs at each administration | ||
| Residual teriparatide in the patch after application |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan | |||||
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Multiple administration of placebo AK159 |
|
| Kumamoto |
| Japan |
| Tokyo | Japan |
| D009750 |
| Nutritional and Metabolic Diseases |