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

NCT ID: NCT02818543

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Cohort 1

LYC-30937 25 mg single oral dose

Group Type EXPERIMENTAL

LYC-30937

Intervention Type DRUG

Cohort 2

LYC-30937 100 mg single oral dose

Group Type EXPERIMENTAL

LYC-30937

Intervention Type DRUG

Interventions

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LYC-30937

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lycera Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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DRC Ltd.

Balatonfüred, , Hungary

Site Status

PRA Magyarorszag Kft

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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LYC-30937-1002

Identifier Type: -

Identifier Source: org_study_id