A Study in Healthy Men and Women to Test Which Effects Memantine and BI 425809 Have on Each Other

A Study to Investigate the Effects of Memantine on the Pharmacokinetics of BI 425809 and Vice Versa in Healthy Male and Female Subjects (Non-randomized, Single-arm, Open-label, Three-period, One Fixed Sequence Cross-over Study)

Investigate the effect of steady state exposures of memantine on the steady-state pharmacokinetics of BI 425809 and vice versa in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 425809; Drug: Memantine

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany, 68167
    • CRS Clinical Research Services Mannheim GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
• Age of 18 to 50 years (inclusive)
• BMI of 18.5 to 29.9 kg/m2 (inclusive)
• 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 from the first administration of trial medication until 30 days after trial completion:

  • Use of adequate contraception that does not contain hormones, i.e. nonhormonal intrauterine device plus condom
  • 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 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) deviating from normal and assessed 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 50 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 assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or 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
• Further exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All subjects	Drug: BI 425809; Film coated tablet; Drug: Memantine; Film coated tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (BI 425809 + Memantine : BI 425809)	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss). Comparison of BI 425809 + Memantine versus BI 425809. Period 1 (BI 425809): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h (10 minutes (min) before the next dosing ) after first administration of BI 425809 on day 10 of Period 1. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 min before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after first administration of BI 425809 + Memantine on day 10 of Period 3.	Detailed time frame is described in the measure description section.
Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (BI 425809 + Memantine : BI 425809)	Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss). Comparison of BI 425809 + Memantine versus BI 425809. Period 1 (BI 425809): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h (10 minutes (min) before the next dosing ) after first administration of BI 425809 on day 10 of Period 1. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 min before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after first administration of BI 425809 + Memantine on day 10 of Period 3.	Detailed time frame can be found in the measure description.
Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (BI 425809 + Memantine : Memantine)	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss). Comparison of BI 425809 + Memantine versus BI 425809. Treatment Period 2 (Memantine): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12 h after administration of Memantine on day 35 of Period 2. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after administration of BI 425809 + Memantine on day 10 of Period 3.	Detailed time frame is described in the measure description section.
Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (BI 425809 + Memantine : Memantine)	Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss). Comparison of BI 425809 + Memantine versus BI Memantine. Treatment Period 2 (Memantine): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12 h after administration of Memantine on day 35 of Period 2. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after administration of BI 425809 + Memantine on day 10 of Period 3.	Detailed time frame can be found in the measure description.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Nootropic Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; BI 425809; Memantine
• Other Study ID Numbers: 1346-0039; 2019-000468-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No