NCT06689527

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

An Open-label, Single-arm Study to Evaluate the CYP3A4 Induction Potential of Vamorolone on the Pharmacokinetics of Midazolam (a Sensitive CYP3A4 Probe) in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Santhera Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to investigate how vamorolone affects the CYP3A4 enzyme in humans by measuring the pharmacokinetics of midazolam and its metabolite, 1'-hydroxymidazolam, in healthy subjects. The pharmacokinetics of midazolam were measured on Day 1 and then on Day 14 to investigate the potential interaction between the two compounds. The safety and the tolerability was also investigated.

Detailed description

This was a non-randomized, single-center, open-label, single-sequence, single-arm Phase I study. * Day 1: Participants received a single dose of 2.5 mg midazolam in fasted state in the morning. * Day 2: Wash-out period. * Days 3 to 13: Participants received daily doses of 6 mg/kg vamorolone in the morning within 30 minutes after start of a standard breakfast. * Day 14: Participants received single doses of 2.5 mg midazolam and 6 mg/kg vamorolone in fasted state in the morning. * Safety and tolerability parameters were collected during the entire study phase from screening to follow-up. * Blood samples for PK assessment of midazolam and 1'-hydroxymidazolam were collected from predose through 10 hours following the midazolam doses on Days 1 and 14. * Blood samples for PK assessment of vamorolone were collected throughout the vamorolone dosing period. * Blood and urine biomarkers samples for CYP3A4 induction assessment were collected throughout the treatment period. * On Day 28, a follow-up safety phone call was done

Conditions

• Drug Interaction

Interventions

Type	Name	Description
DRUG	Vamorolone	Days 3 to 14: 6 mg/kg vamorolone once daily.
DRUG	Midazolam	Day 1 and 14: Single oral doses of 2.5 mg midazolam

Timeline

• Start date: 2024-08-13
• Primary completion: 2024-09-24
• Completion: 2024-10-16
• First posted: 2024-11-14
• Last updated: 2025-12-15
• Results posted: 2025-12-15

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study