NCT03380455

Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Subjects

A Single-center, Open-label Study to Investigate the Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-01-09
• Primary completion: 2018-01-29
• Completion: 2018-01-29
• First posted: 2017-12-21
• Last updated: 2022-06-02

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study