This trial is active, not recruiting.

Condition ulcerative colitis
Treatment lyc-30937
Phase phase 1
Sponsor Lycera Corp.
Start date March 2016
End date June 2016
Trial size 6 participants
Trial identifier NCT02818543, LYC-30937-1002


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
LYC-30937 25 mg single oral dose
LYC-30937 100 mg single oral dose

Primary Outcomes

Maximum observed plasma concentration (Cmax)
time frame: up to 48 hours
Time to maximum observed plasma concentration (Tmax)
time frame: up to 48 hours
Percentage of estimated Area Under the Curve (0-inf)
time frame: up to 48 hours

Secondary Outcomes

Treatment emergent adverse events (TEAEs)
time frame: 7 days post-dose
Clinical laboratory data
time frame: 7 days post-dose
Vital signs
time frame: 7 days post-dose
12-Lead Electrocardiogram (ECG)
time frame: 7 days post-dose

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Lycera Corp..