Clinical trial NCT03988803: A Study in Healthy Men and Women to Test Which Effects Memantine and BI 425809 Have on Each Other
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Detailed time frame is described in the measure description section.
measure: Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (BI 425809 + Memantine : BI 425809)
timeFrame: Detailed time frame can be found in the measure description.
measure: Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (BI 425809 + Memantine : Memantine)
timeFrame: Detailed time frame is described in the measure description section.
measure: Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (BI 425809 + Memantine : Memantine)
timeFrame: Detailed time frame can be found in the measure description.
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: CRS Clinical Research Services Mannheim GmbH
Study officials:
References: