Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female Subjects
- Registration Number
- NCT02635750
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Part I:
To investigate whether and to what extent donepezil affects single dose pharmacokinetics of BI 409306
Part II:
To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics of donepezil
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1) BI 409306 Subjects received treatment in a fixed sequence. First BI 409306 as reference treatment (R1)), then BI 409306 + donepezil as test treatment (T1)). Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2) BI 409306 Subjects received first the test treatment 2 (T2) followed by a washout period, followed by the reference treatment 2 (R2)). Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2) BI 409306 Subjects received first the reference treatment (R2) followed by a washout period, followed by the test treatment (T2). Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1) Donepezil Subjects received treatment in a fixed sequence. First BI 409306 as reference treatment (R1)), then BI 409306 + donepezil as test treatment (T1)). Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2) Donepezil Subjects received first the reference treatment (R2) followed by a washout period, followed by the test treatment (T2). Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2) Donepezil Subjects received first the test treatment 2 (T2) followed by a washout period, followed by the reference treatment 2 (R2)).
- Primary Outcome Measures
Name Time Method Part 2: AUC0-tz of Donepezil At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter. Area under the concentration-time curve of donepezil in plasma over the time interval from 0 to the last quantifiable data point.
Part 1: Cmax of BI 409306 Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter. Maximum measured concentration of the BI 409306 in plasma.
Part 1: AUC0-tz of BI 409306 Within 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14, 16 hours thereafter. Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point.
Part 2: Cmax of Donepezil At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter. Maximum measured concentration of the donepezil in plasma.
- Secondary Outcome Measures
Name Time Method Part 1: AUC 0-infinity of BI 409306 At approximate 3 hours (h) prior to administration of BI 409306 and 10, 20, 30, 45 minutes (min) and 1, 1:30, 2:00, 2:30, 3, 4, 5, 6, 8, 10, 12, 14,16 hours thereafter. Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity.
Part 2: AUC0-infinity of Donepezil At approximate 2 hours (h) prior to first administration of donepezil and 1, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 15, 24:30, 48:30, 72:30, 96:30, 120:30, 144:30, 168:30 hours thereafter. This outcome measure presents the area under the concentration-time curve of donepezil in plasma over the time interval from 0 extrapolated to infinity.
Trial Locations
- Locations (1)
CRS Clinical Research Services Mannheim GmbH
🇩🇪Mannheim, Germany