NCT06689527View on ClinicalTrials.gov

Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 13, 2024

Primary Completion Date

September 24, 2024

Study Completion Date

October 16, 2024

Conditions
Drug Interaction Potentiation
Interventions
DRUG

Vamorolone

Days 3 to 14: 6 mg/kg vamorolone once daily.

DRUG

Midazolam

Day 1 and 14: Single doses of 2.5 mg midazolam

Trial Locations (1)

89231

Nuvisan GmbH, Neu-Ulm

Sponsors
All Listed Sponsors
lead

Santhera Pharmaceuticals

INDUSTRY