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

December 13, 2016 updated by: Lycera Corp.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Balatonfured, Hungary
        • DRC Ltd.
      • Budapest, Hungary
        • PRA Magyarorszag Kft

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
LYC-30937 25 mg single oral dose
Drug: LYC-30937
Experimental: Cohort 2
LYC-30937 100 mg single oral dose
Drug: LYC-30937

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment emergent adverse events (TEAEs)
Time Frame: 7 days post-dose
TEAEs will be listed and summarized by dose and overall
7 days post-dose
Clinical laboratory data
Time Frame: 7 days post-dose
Clinical laboratory data will be listed with flagging of values outside the normal range
7 days post-dose
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
7 days post-dose
12-Lead Electrocardiogram (ECG)
Time Frame: 7 days post-dose
Descriptive statistics will be provided to summarize ECG parameters
7 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lycera Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LYC-30937-1002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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