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The purpose of this study is to determine the pharmacokinetics (PK) and to assess safety and tolerability of a single dose of ASP3291 in subjects with ulcerative colitis.
After an 11-day screening period, subjects check into a clinic, are dosed on Day 1 and stay in the clinic for 4 days to monitor pharmacokinetic and safety parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP3291 low dose | Experimental |
| |
| ASP3291 high dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP3291 | Drug | Oral tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic assessment through analysis of blood, fecal and urine samples | Up to Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States | ||
| SNBL Clinical Pharmacology Center |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo |
| Drug |
Oral tablets |
|
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |