drugset / Trial / NCT06689527
Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics
NaSingle-groupOpen-labelOther
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.
Timeline
- Start
- 2024-08-13
- Primary completion
- 2024-09-24
- Completion
- 2024-10-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 2.5 mg | Oral |
| Subject | Vamorolone | Small molecule | 6 mg/kg | Oral |
Indications
No indication recorded.