NCT01452542

A Phase I Study of the Pharmacokinetic Variability and Relative Bioavailability of the Phase 3 and Common Blend Formulations of Eliglustat in Healthy Adult Subjects

A Pilot, Phase 1, Single-site, Single-dose, Randomized, Open-label, Two-treatment, Two-sequence, Four-period Replicated Crossover Study Evaluating the Within-subject Pharmacokinetic Variability and Relative Bioavailability of the Phase 3 and Common Blend Formulations of Eliglustat in Healthy Adult Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this pilot study is to determine the within-subject pharmacokinetic (PK) variability and relative bioavailability of single oral 150-mg doses of eliglustat administered as the Phase 3 formulation (3x50-mg capsules) and the common blend proposed commercial formulation (1x150-mg capsule) in healthy adult subjects, which will be used to plan and support the design of a subsequent bioequivalence study.

Detailed description

This will be a single-site, single-dose, randomized, open-label, two-treatment, two-sequence, four-period replicated crossover study in healthy adult subjects. The study will comprise a screening period, four treatment periods with a 7-day washout between dosing in each period, and a safety follow-up visit.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Eliglustat, common blend proposed commercial formulation	All participants will receive a single oral 150-mg dose of the common blend proposed commercial formulation of eliglustat, administered as one 150-mg strength capsule (Treatment T), on 2 separate dosing occasions.
DRUG	Eliglustat, Phase 3 capsule formulation	All participants will receive a single oral 150-mg dose of the Phase 3 capsule formulation of eliglustat, administered as three 50-mg strength capsules (Treatment R), on 2 separate dosing occasions.

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-10-17
• Last updated: 2015-03-23

Locations

1 site across 1 country: United States