At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effect of Zongertinib on the Pharmacokinetics of Dabigatran (Part 1) and Rosuvastatin, Metformin and Furosemide Administered as a Cocktail (Part 2) in Healthy Male Subjects (a 2-part, Open-label, 2-period, Fixed-sequence Cross-over Trial)
In Brief
A Phase 1 clinical trial evaluating Zongertinib, Dabigatran-etexilate, and 3 other interventions for Healthy. Completed, enrolled 32 participants across 1 site.
Detailed Summary
For Part 1 of the trial, the main objective is to assess the effect of a single dose of zongertinib on the pharmacokinetics of a single dose of dabigatran-etexilate. For Part 2 of the trial, the main objective is to assess the effect of zongertinib at steady-state on the pharmacokinetics of a single dose of rosuvastatin, metformin and furosemide (administered as a cocktail).
Study Details
Timeline
Interventions
A 120 mg dose on Day 1 of period 2 (Part 1) OR daily (Part 2) with 240 mL of water after an overnight fast of at least 10 hours.
A 150 mg dose on Day 1 of each period with 240 mL of water after an overnight fast of at least 10 hours.
A 10 mg dose on Day 1 of each period with 240 mL of water after an overnight fast of at least 10 hours.
A 10 mg dose on Day 1 of each period with 240 mL of water after an overnight fast of at least 10 hours.
A 1 mg dose on Day 1 of each period with 240 mL of water after an overnight fast of at least 10 hours.