At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1584862 in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Design Study)
In Brief
A Phase 1 clinical trial evaluating BI 1584862 and Itraconazole for Healthy. Completed, enrolled 14 participants across 1 site.
Signals
Detailed Summary
The main objective of this trial is to investigate the effect on the exposure of BI 1584862 in plasma when given as single dose together with multiple doses of itraconazole (Test, T) as compared to BI 1584862 when given alone as oral single dose (Reference, R).
Study Details
Timeline
Arms & Interventions
Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Test treatment (T): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 milligram (mg) itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days. The two administrations of BI 1584862 were separated by a washout period.
Interventions
One dose with 240 mL of water after an overnight fast of at least 10 h
200 mg daily after an overnight fast of at least 9 h for several consecutive days