A Study to Investigate the Pharmacokinetic Drug-drug Interaction Following Oral Administration of BI 409306 and Donepezil in Healthy Male and Female Subjects
Overview
- Phase
- Phase 1
- Intervention
- BI 409306
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Part 2: AUC0-tz of Donepezil
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1)
Subjects received treatment in a fixed sequence. First BI 409306 as reference treatment (R1)), then BI 409306 + donepezil as test treatment (T1)).
Intervention: BI 409306
Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1)
Subjects received treatment in a fixed sequence. First BI 409306 as reference treatment (R1)), then BI 409306 + donepezil as test treatment (T1)).
Intervention: Donepezil
Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2)
Subjects received first the reference treatment (R2) followed by a washout period, followed by the test treatment (T2).
Intervention: BI 409306
Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2)
Subjects received first the reference treatment (R2) followed by a washout period, followed by the test treatment (T2).
Intervention: Donepezil
Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2)
Subjects received first the test treatment 2 (T2) followed by a washout period, followed by the reference treatment 2 (R2)).
Intervention: BI 409306
Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2)
Subjects received first the test treatment 2 (T2) followed by a washout period, followed by the reference treatment 2 (R2)).
Intervention: Donepezil
Outcomes
Primary Outcomes
Part 2: AUC0-tz of Donepezil
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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.)
- 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.)