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

Phase 1

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: LYC-30937

• Registration Number: NCT02818543
• Lead Sponsor: Lycera Corp.

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-30
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-29
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-13
• Last Update Posted: 2016-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	LYC-30937	LYC-30937 25 mg single oral dose
Cohort 2	LYC-30937	LYC-30937 100 mg single oral dose

Primary Outcome Measures

Name	Time	Method
Time to maximum observed plasma concentration (Tmax)	up to 48 hours	Measure specified pharmacokinetic parameters pre-dose and out to 48 hours
Maximum observed plasma concentration (Cmax)	up to 48 hours	Measure specified pharmacokinetic parameters pre-dose and out to 48 hours post-dose
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 Outcome Measures

Name	Time	Method
Treatment emergent adverse events (TEAEs)	7 days post-dose	TEAEs will be listed and summarized by dose and overall
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
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

Trial Locations

Locations (2)

PRA Magyarorszag Kft; 🇭🇺 Budapest, Hungary

DRC Ltd.; 🇭🇺 Balatonfured, Hungary