Clinical Trial 45953

Long Beach, CA 90806


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 in males only.

  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

Qualified Participants May Receive:

Compensation for participating up to $3,800 over the study length of 90 days.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.