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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02818543
Other study ID # LYC-30937-1002
Secondary ID
Status Completed
Phase Phase 1
First received March 30, 2016
Last updated December 13, 2016
Start date March 2016
Est. completion date June 2016

Study information

Verified date December 2016
Source Lycera Corp.
Contact n/a
Is FDA regulated No
Health authority Hungary: National Institute of Pharmacy
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
LYC-30937


Locations

Country Name City State
Hungary DRC Ltd. Balatonfured
Hungary PRA Magyarorszag Kft Budapest

Sponsors (1)

Lead Sponsor Collaborator
Lycera Corp.

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum observed plasma concentration (Cmax) Measure specified pharmacokinetic parameters pre-dose and out to 48 hours post-dose up to 48 hours No
Primary Time to maximum observed plasma concentration (Tmax) Measure specified pharmacokinetic parameters pre-dose and out to 48 hours up to 48 hours No
Primary Percentage of estimated Area Under the Curve (0-inf) Measure specified pharmacokinetic parameters pre-dose and out to 48 hours up to 48 hours No
Secondary Treatment emergent adverse events (TEAEs) TEAEs will be listed and summarized by dose and overall 7 days post-dose No
Secondary Clinical laboratory data Clinical laboratory data will be listed with flagging of values outside the normal range 7 days post-dose No
Secondary Vital signs descriptive statistics will be provided to summarize vital signs and changes from baseline by dose at each scheduled time 7 days post-dose No
Secondary 12-Lead Electrocardiogram (ECG) Descriptive statistics will be provided to summarize ECG parameters 7 days post-dose No
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