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Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Subjects

NCT03380455 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-06-02

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

Lucerastat

Single oral dose of 500 mg lucerastat under fasted conditions

DRUG

Cimetidine

Twice daily oral dose of 800 mg cimetidine under fasted conditions

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Marie-Laure Boof, PhD · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-09
Primary Completion
2018-01-29
Completion
2018-01-29
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03380455 on ClinicalTrials.gov