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

Ulcerative Colitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818543
• Other study ID #: LYC-30937-1002
• 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

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

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