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drugset / Trial / NCT05127564

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants

NCT05127564 ↗

Phase 1 Completed 32 enrolled Biogen
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and Caucasian adult healthy participants. The secondary objectives are to evaluate the secondary PK parameters of DRF active metabolite MMF following multiple doses of DRF in Chinese and Caucasian adult healthy participants, to evaluate the PK of DRF inactive major metabolite 2-hydroxyethyl succinimide (HES) following multiple doses of DRF in Chinese and Caucasian adult healthy participants and to evaluate the safety and tolerability of multiple oral doses of DRF in Chinese and Caucasian adult healthy participants.

Timeline

Start
2021-12-03
Primary completion
2022-06-09
Completion
2022-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Diroximel fumarate Small molecule — Oral

Indications

No indication recorded.