Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female Subjects

A Study to Investigate the Pharmacokinetic Drug-drug Interaction Following Oral Administration of BI 409306 and Donepezil in Healthy Male and Female Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 409306; Drug: Donepezil low dose; Drug: Donepezil high dose

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany
    • Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 409306	Drug: BI 409306
Experimental: Donepezil low dose	Drug: Donepezil low dose
Experimental: Donepezil high dose	Drug: Donepezil high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In Part 1: AUC0-tz	up to 16 hours
In Part 1: Cmax	up to 16 hours
In part 2: AUC0-tz	up to 168.5 hours
In part 2: Cmax	up to 168.5 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
In Part 1: AUC 0-infinity	up to 16 hours
In Part 2: AUC0-infinity	up to 168.5 hours

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil; BI 409306
• Other Study ID Numbers: 1289.24; 2015-001694-40 (EudraCT Number: EudraCT)