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
1 other identifier
interventional
6
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2016
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedDecember 14, 2016
December 1, 2016
3 months
March 30, 2016
December 13, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Treatment emergent adverse events (TEAEs)
7 days post-dose
Clinical laboratory data
7 days post-dose
Vital signs
7 days post-dose
12-Lead Electrocardiogram (ECG)
7 days post-dose
Study Arms (2)
Cohort 1
EXPERIMENTALLYC-30937 25 mg single oral dose
Cohort 2
EXPERIMENTALLYC-30937 100 mg single oral dose
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lycera Corp.lead
Study Sites (2)
DRC Ltd.
Balatonfüred, Hungary
PRA Magyarorszag Kft
Budapest, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2016
First Posted
June 29, 2016
Study Start
March 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
December 14, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share