A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants
NCT06679413 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2026-03-30
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
- 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
-
Study participants will receive a pre-specified single oral dose of probe drug metformin on Day 1 and Day 22 of the study
- DRUG
-
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
Sponsors & Collaborators
-
UCB BIOSCIENCES, Inc.
lead INDUSTRY
Principal Investigators
-
UCB Cares · 001 844 599 2273 (UCB)
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-04
- Primary Completion
- 2025-06-12
- Completion
- 2025-06-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
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