NCT02818543 is a Phase 1 clinical trial of LYC-30937 in Ulcerative Colitis, sponsored by Lycera Corp..

Who is sponsoring NCT02818543?

NCT02818543 is sponsored by Lycera Corp..

What drugs are being tested in NCT02818543?

Interventions in NCT02818543: LYC-30937.

What condition does NCT02818543 study?

NCT02818543 studies Ulcerative Colitis.

Is NCT02818543 still recruiting?

NCT02818543 is currently completed. Last updated 13 December 2016.

Last reviewed 2016-12-13 · How we verify

NCT02818543

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 13 December 2016

What this trial tests

Phase 1 trial testing LYC-30937 in Ulcerative Colitis in 6 participants. Completed in 1 June 2016.

Timeline

1 March 2016

Primary endpoint
1 June 2016

1 June 2016

Quick facts

Lead sponsor	Lycera Corp.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Enrollment	6
Start date	1 March 2016
Primary completion	1 June 2016
Estimated completion	1 June 2016
Sites	2 locations across Hungary

Drugs / interventions tested

LYC-30937 — full drug profile →

Conditions studied

Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Lycera Corp. — full company profile →

Who can join

Adults 18 to 75, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Ulcerative Colitis

Currently open trials in the same condition.

NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting

Other Lycera Corp. trials

Trials by the same sponsor.

NCT03396497 — Study of LYC-55716 With Pembrolizumab in Adult Subjects With Non-Small Cell Lung Cancer · Phase 1 · unknown
NCT02872285 — An Efficacy and Safety Study of LYC-30937-EC in Subjects With Moderate Chronic Plaque-type Psoriasis · Phase 2 · completed
NCT02764229 — Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02818543 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lycera Corp.
Last refreshed: 13 December 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02818543.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing