Clinical trial NCT02635750: Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female Subjects
Official title: A Study to Investigate the Pharmacokinetic Drug-drug Interaction Following Oral Administration of BI 409306 and Donepezil in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-12-21
Enrollment: 32
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria:

* Healthy male/female subjects,
* age of 18 to 55 years,
* body mass index (BMI) of 18.5 to 29.9 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
* Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:
* Use of adequate contraception, e.g. any of the following methods plus condom:

intrauterine device (non-hormonal)

* Sexually abstinent
* A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
* Surgically sterilised (including hysterectomy)
* Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 60 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections
* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
* Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
* Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
* Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
* Smoker
* Alcohol abuse Further exclusion criteria apply

Primary outcomes:
measure: Part 1: AUC0-tz of BI 409306
timeFrame: 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.
measure: Part 1: Cmax of BI 409306
timeFrame: 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.
measure: Part 2: AUC0-tz of Donepezil
timeFrame: 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.
measure: Part 2: Cmax of Donepezil
timeFrame: 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.
Secondary outcomes:
measure: Part 1: AUC 0-infinity of BI 409306
timeFrame: 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.
measure: Part 2: AUC0-infinity of Donepezil
timeFrame: 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.
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: CRS Clinical Research Services Mannheim GmbH
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: