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

NCT02635750 | Completed Phase 1 Results

• 2 other identifiers: 1289.242015-001694-40
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Part 1: AUC0-tz of BI 409306

  Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point.

  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.

• Part 1: Cmax of BI 409306

  Maximum measured concentration of the BI 409306 in plasma.

  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.

• Part 2: AUC0-tz of Donepezil

  Area under the concentration-time curve of donepezil in plasma over the time interval from 0 to the last quantifiable data point.

  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.

• Part 2: Cmax of Donepezil

  Maximum measured concentration of the donepezil in plasma.

  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 (2)

• 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.

Study Arms (3)

Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1)

EXPERIMENTAL

Subjects received treatment in a fixed sequence. First BI 409306 as reference treatment (R1)), then BI 409306 + donepezil as test treatment (T1)).

Drug: BI 409306; Drug: Donepezil

Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2)

EXPERIMENTAL

Subjects received first the reference treatment (R2) followed by a washout period, followed by the test treatment (T2).

Drug: BI 409306; Drug: Donepezil

Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2)

EXPERIMENTAL

Subjects received first the test treatment 2 (T2) followed by a washout period, followed by the reference treatment 2 (R2)).

Drug: BI 409306; Drug: Donepezil

Interventions

BI 409306 DRUG

Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1); Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2); Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2)

Donepezil DRUG

Part 1: 25 mg BI 409306 (R1) / 25 mg BI 409306 + 10 mg donepezil (T1); Part 2: 5 mg donepezil (R2) / 5 mg donepezil + 100 mg BI 409306 (T2); Part 2: 5 mg donepezil + 100 mg BI 409306 (T2) / 5 mg donepezil (R2)

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

BI 409306; Donepezil

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 21, 2015
• Study Start: January 15, 2016
• Primary Completion: March 16, 2016
• Study Completion: April 4, 2016
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)