NCT Number: NCT02818543
Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis
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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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
DRC Ltd., Balatonfüred, Hungary
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Maximum observed plasma concentration (Cmax)
Time frame: up to 48 hours
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours post-dose
-
Time to maximum observed plasma concentration (Tmax)
Time frame: up to 48 hours
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours
-
Percentage of estimated Area Under the Curve (0-inf)
Time frame: up to 48 hours
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours
Secondary outcomes
-
Treatment emergent adverse events (TEAEs)
Time frame: 7 days post-dose
TEAEs will be listed and summarized by dose and overall
-
Clinical laboratory data
Time frame: 7 days post-dose
Clinical laboratory data will be listed with flagging of values outside the normal range
-
Vital signs
Time frame: 7 days post-dose
descriptive statistics will be provided to summarize vital signs and changes from baseline by dose at each scheduled time
-
12-Lead Electrocardiogram (ECG)
Time frame: 7 days post-dose
Descriptive statistics will be provided to summarize ECG parameters
Sponsors and collaborators
Lead sponsor
Lycera Corp.
Industry
Registry information
Official study 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
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jun 29, 2016
- Registry last updated
- Dec 14, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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