NCT03905096

A Study in Healthy Men and Women to Test Which Effects Donepezil and BI 425809 Have on Each Other

A Study to Investigate the Effects of Donepezil on the Pharmacokinetics of BI 425809 and Vice Versa in Healthy Male and Female Subjects (Open-label, Two-treatment, Two-period, One Fixed Sequence Cross-over Design)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main objective of Part 1of this trial is to investigate the effect of co-administration of multiple doses of donepezil on the single-dose pharmacokinetics of BI 425809 in healthy subjects. In Part 2 the main objective is the investigation of the effect of co-administration of multiple doses of BI 425809 on the single-dose pharmacokinetics of donepezil in healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 425809	Film coated tablet
DRUG	Donepezil	Film coated tablet

Timeline

• Start date: 2019-04-12
• Primary completion: 2019-08-30
• Completion: 2019-08-30
• First posted: 2019-04-05
• Last updated: 2021-02-17
• Results posted: 2021-02-17

Locations

1 site across 1 country: Germany