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The purpose of this study to assess the pharmacokinetic profile in patients with active ulcerative colitis and compare it to the experience in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | LYC-30937 25 mg single oral dose |
|
| Cohort 2 | Experimental | LYC-30937 100 mg single oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LYC-30937 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Measure specified pharmacokinetic parameters pre-dose and out to 48 hours post-dose | up to 48 hours |
| Time to maximum observed plasma concentration (Tmax) | Measure specified pharmacokinetic parameters pre-dose and out to 48 hours | up to 48 hours |
| Percentage of estimated Area Under the Curve (0-inf) | Measure specified pharmacokinetic parameters pre-dose and out to 48 hours | up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment emergent adverse events (TEAEs) | TEAEs will be listed and summarized by dose and overall | 7 days post-dose |
| Clinical laboratory data | Clinical laboratory data will be listed with flagging of values outside the normal range |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DRC Ltd. | Balatonfüred | Hungary | ||||
| PRA Magyarorszag Kft |
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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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| 7 days post-dose |
| Vital signs | descriptive statistics will be provided to summarize vital signs and changes from baseline by dose at each scheduled time | 7 days post-dose |
| 12-Lead Electrocardiogram (ECG) | Descriptive statistics will be provided to summarize ECG parameters | 7 days post-dose |
| Budapest |
| Hungary |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |