Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1152-9381 | Registry Identifier | WHO |
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
Not provided
Not provided
Not provided
The objective of this clinical trial is to examine the clinical pharmacology properties of TAK-233 in healthy female subjects
The primary objective of this study is to examine the pharmacodynamics and the safety of TAK-233 administered as a single dose in healthy women.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-233 | Experimental | Oral administration |
|
| Placebo | Placebo Comparator | Oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-233 | Drug | Oral administration of TAK-233 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in motor threshold for urethral sphincter contraction. | 0.5 hours post-dose | |
| Change from baseline in motor threshold for urethral sphincter contraction. | 3 hours post-dose | |
| Change from baseline in motor threshold for urethral sphincter contraction. | 6 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Treatment emergent adverse events, vital signs, weight, safety ECG, and clinical laboratory tests (hematology, serum chemistry, and urinalysis). | Up to 28 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
22. Subjects unlikely to comply with the protocol, or subjects the investigator or sub-investigator considers ineligible for participation in the clinical trial due to other reasons
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| General Manager | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kumamoto | Kumamoto | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral admininstration of Placebo |
|