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