Clinical trial NCT04602221: A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
Official title: A Randomized, Placebo Controlled, Double-blind, Double-dummy Three-way Cross Over Trial to Investigate the Effect of BI 409306, BI 425809 and Lamotrigine on Ketamine-induced Cognitive Deficits in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-10-26
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 3-treatment period design
Primary purpose: TREATMENT

Brief summary: The main objective of this trail is to investigate if and to what extent BI 409306, BI 425809 and lamotrigine attenuate ketamine induced cognitive deficits.


Eligibility criteria: Inclusion Criteria:

1. Healthy male 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
2. Age of 18 to 55 years (inclusive)
3. BMI of 18.5 to 32 kg/m2 (inclusive)
4. Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
5. Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

   * Use of adequate contraception, e.g. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide)
   * Sexually abstinent
   * Vasectomised (vasectomy at least 1 year prior to enrolment)
   * Surgically sterilised female partner (including hysterectomy, bilateral tubal occlusion or bilateral oophorectomy)
   * Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea

Exclusion Criteria:

1. Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 100 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
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. History of diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply

Primary outcomes:
measure: Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine
timeFrame: At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.
Secondary outcomes:
measure: Spatial Working Memory (SWM) Between Errors (BE468) on Ketamine
timeFrame: At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.
measure: Rapid Visual Information Processing A' Prime (RVPA) on Ketamine
timeFrame: At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
Study officials:
References: