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
Not provided
Not provided
Not provided
The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics and safety following the administration of ASP1941 and pioglitazone hydrochloride in multiple and single doses.
All subjects will be enrolled at one center and confined to the unit for up to 23 days. Subjects will be dosed in the fasting state in one of the four groups.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing Regimen 1 | Experimental |
| |
| Dosing Regimen 2 | Experimental |
| |
| Dosing Regimen 3 | Experimental |
| |
| Dosing Regimen 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1941 | Drug | oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables assessment through analysis of blood samples | Day 1 and up to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic variables assessment through analysis of blood and urine samples | Day -1 and up to Day 17 | |
| Safety assessed by recording of adverse events, laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations | Day 1 through scheduled group check out (Day 13 and up to Day 21) or early termination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | 33014 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| pioglitazone hydrochloride | Drug | oral tablet |
|
|
| ID | Term |
|---|---|
| C572941 | ipragliflozin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided