At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Vamorolone +1 moredrug
Likely dose
Vamorolone 6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 1 clinical trial evaluating Vamorolone and Midazolam for Drug Interaction. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Interaction
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
Enrollment StartAug 2024
Primary CompletionSep 2024
Study CompletionOct 2024
First PostedNov 2024
TodayJul 2026
First PostedNov 14, 2024
Enrollment StartAug 13, 2024
Primary CompletionSep 24, 2024
Study CompletionOct 16, 2024
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 1.6 years ago
Interventions
Vamorolonedrug
Days 3 to 14: 6 mg/kg vamorolone once daily.
Midazolamdrug
Day 1 and 14: Single oral doses of 2.5 mg midazolam