Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: LYC-30937


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active ulcerative colitis defined as a Mayo endoscopy score of ≥ 2 despite therapy. Male or female age 18 to 75 May be receiving a therapeutic dose of an oral 5-amino salicylic acid compound or oral corticosteroid therapy Exclusion Criteria: Current anti-tumor necrosis factor use Current immunosuppressant use (Note: this does not include corticosteroid use) Subjects with only distal active disease (i.e. proctitis) Clinically significant active infection Known bleeding disorder, a risk of bleeding or hypercoagulable disorders in which an anticoagulant is required History of malignancy within the last 5 years except non-melanoma skin cancer or cervical carcinoma in situ Clinically significant lab abnormalities (i.e. liver function abnormalities, renal insufficiency, abnormal absolute neutrophil count or hemoglobin) History of colon resection Any other investigational therapy or investigational biologics use within 8 weeks of investigational medicinal product administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>LYC-30937 25 mg single oral dose | Drug: LYC-30937<br> <br> |
| Experimental: Cohort 2<br>LYC-30937 100 mg single oral dose | Drug: LYC-30937<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |