NCT06679413

A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants

A Phase 1, Single-Center, Repeat-Dose, Open-Label, Fixed-Sequence Drug-Drug Interaction Study of ZX008 in Healthy Male Or Female Study Participants 18 To 55 Years Of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the single-dose pharmacokinetics (PK) of 3 probe drugs (midazolam, bupropion, and metformin) before and after repeat doses of ZX008

Conditions

• Healthy Study Participants

Interventions

Type	Name	Description
DRUG	midazolam	Study participants will receive a pre specified single oral dose of probe drug midazolam on Day 1 and Day 22 of the study
DRUG	metformin	Study participants will receive a pre-specified single oral dose of probe drug metformin on Day 1 and Day 22 of the study
DRUG	bupropion	Study participants will receive a pre-specified single oral dose of probe drug bupropion on Day 1 and Day 22 of the study
DRUG	fenfluramine HCl	Study participants will receive pre-specified repeated oral doses of fenfluramine HCl (ZX008) from Day 6 to 26 during the study

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-06-12
• Completion: 2025-06-12
• First posted: 2024-11-07
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study