NCT06193304

A Study to Evaluate Pharmacokinetic Parameters and Safety of Eliglustat Absorption Through the Mouth

An Open-label Study to Assess the Absorption Through the Mouth After Three Repeated 50 mg Doses of Eliglustat Solution, Separated by 2-hour Intervals, Held in the Mouth for 30 Seconds With Swishing But Without Ingestion, in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (planned)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A study to assess the absorption of eliglustat through the mouth in healthy subjects and the safety of any systemic exposure resulting from oral surface absorption of eliglustat in healthy subjects.

Detailed description

Duration of the study for each subject, not including screening, will be 3 days including follow-up.

Conditions

• Gaucher's Disease

Interventions

Type	Name	Description
DRUG	Eliglustat	Pharmaceutical form:solution -Route of administration: Oral wihtout ingestion

Timeline

• Start date: 2014-08-25
• Primary completion: 2014-09-21
• Completion: 2014-09-21
• First posted: 2024-01-05
• Last updated: 2024-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study