Clinical TrialHealthy VolunteersPlaceboCompleted

A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine

Randomised, placebo-controlled, triple-blind three-period crossover trial (n=40) in healthy men testing whether BI 409306, BI 425809 or lamotrigine reverse ketamine-induced cognitive deficits.

Target Enrollment
40 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

Primary objective is to investigate whether BI 409306, BI 425809 and lamotrigine attenuate ketamine-induced cognitive deficits in healthy male participants.

Randomized, triple-masked, double-dummy three-treatment period crossover with matched placebo; participants receive each treatment in separate periods (total n=40, tablets/film-coated tablets). Cognitive assessments performed after ketamine challenge to measure memory and related outcomes.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Lamotrigine

experimental

Oral lamotrigine tablet as one treatment period in three-period crossover.

Interventions

  • Compound
    via Oral• per period

    Lamotrigine (tablet) as one treatment in crossover; dose not specified in registry fragment.

BI 409306

experimental

Oral BI 409306 film-coated tablet as one treatment period in three-period crossover.

Interventions

  • Compound
    via Oral• per period

    BI 409306 (film-coated tablet); dose not specified in registry fragment.

BI 425809

experimental

Oral BI 425809 film-coated tablet as one treatment period in three-period crossover.

Interventions

  • Compound
    via Oral• per period

    BI 425809 (film-coated tablet); dose not specified in registry fragment.

Placebo

inactive

Matched placebo tablet used as control in crossover sequences.

Interventions

  • Placebo
    via Oral• per period

    Placebo tablet (film-coated).

Participants

Ages
18 – 55
Sexes
male

Inclusion 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

  • 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

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment40 participants
  • Timeline
    Start: 2020-12-01
    End: 2022-08-12
  • Compound
    Placebo
  • Topic
    Healthy Volunteers

Locations

Collaborative Neuroscience Research, LLC — Long Beach, California, United States
Hassman Research Institute — Marlton, New Jersey, United States

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