Trial | NCT02818543  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    6
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.
Study Started
Mar 31
2016
Primary Completion
Jun 30
2016
Study Completion
Jun 30
2016
Last Update
Dec 14
2016
Estimate

Drug LYC-30937

Cohort 1 Experimental

LYC-30937 25 mg single oral dose

Cohort 2 Experimental

LYC-30937 100 mg single oral dose

Criteria 

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
No Results Posted