At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
zongertinib +3 moredrug
Likely dose
zongertinib 120 mgfrom 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.
The Effect of Multiple Doses of Zongertinib on the Single-dose Pharmacokinetics of Midazolam, Omeprazole and Repaglinide in Healthy Male Subjects (an Open-label, 2-period, Fixed-sequence Trial)
In Brief
A Phase 1 clinical trial evaluating zongertinib, midazolam, and 2 other interventions for Healthy. Completed, enrolled 16 participants across 1 site.
Detailed Summary
The main objective of this trial is to assess the effect of multiple oral doses of zongertinib on the pharmacokinetics of midazolam, omeprazole and repaglinide.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
First PostedJul 2024
Enrollment StartJul 2024
Primary CompletionOct 2024
TodayJul 2026
First PostedJul 10, 2024
Enrollment StartJul 30, 2024
Primary CompletionOct 16, 2024
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2.0 years ago
Interventions
zongertinibdrug
Participants received 120 mg Zongertinib daily as two 60 mg tablets.
midazolamdrug
Participants received 1 mg Midazolam as 0.5 mL oral solution.
omeprazoledrug
Participants received 20 mg Omeprazole.
repaglinidedrug
Participants received a 0.5 mg Repaglinide.