NCT03380455 is a Phase 1 clinical trial of Lucerastat in Healthy Subjects, sponsored by Idorsia Pharmaceuticals Ltd..

Who is sponsoring NCT03380455?

NCT03380455 is sponsored by Idorsia Pharmaceuticals Ltd..

What drugs are being tested in NCT03380455?

Interventions in NCT03380455: Lucerastat, Cimetidine.

What condition does NCT03380455 study?

NCT03380455 studies Healthy Subjects.

Is NCT03380455 still recruiting?

NCT03380455 is currently completed. Last updated 2 June 2022.

Last reviewed 2022-06-02 · How we verify

NCT03380455

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

Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Subjects

Completed Phase 1 Last updated 2 June 2022

What this trial tests

Phase 1 trial testing Lucerastat in Healthy Subjects in 14 participants. Completed in 29 January 2018.

Timeline

9 January 2018

Primary endpoint
29 January 2018

29 January 2018

Quick facts

Lead sponsor	Idorsia Pharmaceuticals Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	other
Enrollment	14
Start date	9 January 2018
Primary completion	29 January 2018
Estimated completion	29 January 2018
Sites	1 location across Germany

Drugs / interventions tested

Lucerastat — full drug profile →
Cimetidine (CIMETIDINE) — full drug profile →

Conditions studied

Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

Idorsia Pharmaceuticals Ltd. — full company profile →

Who can join

Adults 18 to 45, male only, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A study in healthy male subjects to investigate whether repeated administrations of cimetidine (a medication which decreases the amount of acid in the stomach) can affect the fate in the body (amount and time of presence in the blood) of lucerastat. Safety of the concomitant administration of the two treatments will also be assessed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Impact of the organic cation transporter 2 inhibitor cimetidine on the single-dose pharmacokinetics of the glucosylceramide synthase inhibitor lucerastat in healthy subjects.
Boof ML, Halabi A, Ufer M, Dingemanse J. · · 2020 · cited 6× · PMID 31836927 · DOI 10.1007/s00228-019-02808-9

Verify or expand the search:

Other trials of Lucerastat

Trials testing the same drug.

NCT03425539 — Efficacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With Fabry Disease · Phase 3 · completed
NCT02930655 — A Study to Assess the Safety and Tolerability of Lucerastat in Subjects With Fabry Disease · Phase 1 · completed

Other recruiting trials for Healthy Subjects

Currently open trials in the same condition.

NCT07222020 — Phase 1 Study of Intravaginal KB15A · Phase 1 · recruiting
NCT07350538 — The Critical Link Between Gut Microbiome Dysfunction, Cravings and Relapse: RECLAIM-GUT TRIAL · NA · active not recruiting
NCT07304791 — This is a Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics (PK), and P · Phase 1 · recruiting
NCT07059858 — Bladder and Bowel Functions, Participation and Quality of Life in Children With Intellectual Disabilities · recruiting
NCT07331389 — A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin · Phase 1 · recruiting

Other Idorsia Pharmaceuticals Ltd. trials

Trials by the same sponsor.

NCT06799884 — A Drug-drug Interaction Trial in Healthy Female Participants to Investigate the Effect of Aprocitentan on Combined Hormo · Phase 1 · completed
NCT05877222 — A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in · Phase 1 · completed
NCT05597020 — A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia · Phase 4 · completed
NCT05632393 — A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women · Phase 1 · completed
NCT05702177 — A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to · Phase 1 · completed

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 NCT03380455 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Idorsia Pharmaceuticals Ltd.
Last refreshed: 2 June 2022

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/NCT03380455.

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