NCT06188325

A Study to Evaluate Pharmacokinetic Parameters of Eliglustat in Healthy Volunteers Who Are CYP2D6 Extensive or Poor Metabolizers

A Randomized, Three-Period Crossover Study of Single and Repeated Doses for Three Different Strengths of Eliglustat in Healthy Adult, CYP2D6 Extensive and Poor Metabolizers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate dose proportionality and pharmacokinetics for three different dose levels of eliglustat after single and repeated administration.

Detailed description

Duration of the study for each subject will be between 42 to 79 days, including a screening period up to 28 days, 3 treatment periods of 7 days each period, a washup period of 7-10 days, and an end-of-study visit 8+/-2 days after the last administration.

Conditions

• Gaucher's Disease

Interventions

Type	Name	Description
DRUG	Eliglustat	Pharmaceutical form:Capsule-Route of administration:Oral

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-03-26
• Completion: 2018-03-26
• First posted: 2024-01-03
• Last updated: 2024-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study