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Completed

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DRC Ltd., Balatonfüred, Hungary

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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

LYC-30937

Drug

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: up to 48 hours

    Measure specified pharmacokinetic parameters pre-dose and out to 48 hours post-dose

  2. Time to maximum observed plasma concentration (Tmax)

    Time frame: up to 48 hours

    Measure specified pharmacokinetic parameters pre-dose and out to 48 hours

  3. 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

  1. Treatment emergent adverse events (TEAEs)

    Time frame: 7 days post-dose

    TEAEs will be listed and summarized by dose and overall

  2. Clinical laboratory data

    Time frame: 7 days post-dose

    Clinical laboratory data will be listed with flagging of values outside the normal range

  3. 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

  4. 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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