Ulcerative Colitis
Conditions
Brief summary
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.
Interventions
DRUGLYC-30937
Sponsors
Lycera Corp.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | up to 48 hours | Measure specified pharmacokinetic parameters pre-dose and out to 48 hours post-dose |
| Time to maximum observed plasma concentration (Tmax) | up to 48 hours | Measure specified pharmacokinetic parameters pre-dose and out to 48 hours |
| Percentage of estimated Area Under the Curve (0-inf) | up to 48 hours | Measure specified pharmacokinetic parameters pre-dose and out to 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent adverse events (TEAEs) | 7 days post-dose | TEAEs will be listed and summarized by dose and overall |
| 12-Lead Electrocardiogram (ECG) | 7 days post-dose | Descriptive statistics will be provided to summarize ECG parameters |
| Clinical laboratory data | 7 days post-dose | Clinical laboratory data will be listed with flagging of values outside the normal range |
| Vital signs | 7 days post-dose | descriptive statistics will be provided to summarize vital signs and changes from baseline by dose at each scheduled time |
Countries
Hungary
Outcome results
None listed