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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04602221
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : March 8, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lamotrigine Drug: BI 409306 Drug: Placebo Drug: BI 425809 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 3-treatment period design
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : April 11, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lamotrigine treatment (T1) Drug: Lamotrigine
Tablet
Experimental: BI 409306 treatment (T2) Drug: BI 409306
Film-coated tablet
Placebo Comparator: Placebo treatment (R) Drug: Placebo
Tablet, Film-coated tablet
Experimental: BI 425809 treatment (T3) Drug: BI 425809
Film-coated tablet


Outcome Measures
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Primary Outcome Measures :
  1. Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on ketamine [ Time Frame: up to 41 days ]

Secondary Outcome Measures :
  1. Spatial Working Memory (SWM) Between Errors (BE468) on ketamine [ Time Frame: up to 41 days ]
  2. Rapid Visual Information Processing A' Prime (RVPA) on ketamine [ Time Frame: up to 41 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602221


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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United States, California
Collaborative Neuroscience Research, LLC Recruiting
Long Beach, California, United States, 90806
Contact: David Walling    +001 (714) 799-7799    davidwalling@cnstrial.com   
United States, New Jersey
Hassman Research Institute Recruiting
Marlton, New Jersey, United States, 08053
Contact: Howard Hassman    +001 (856) 753-7335-x350    hhassman@hritrials.com   
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04602221    
Other Study ID Numbers: 1289-0057
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lamotrigine
BI 425809
BI 409306
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Nootropic Agents