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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04602221
Recruitment Status : Completed
First Posted : October 26, 2020
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE October 16, 2020
First Posted Date  ICMJE October 26, 2020
Last Update Posted Date August 22, 2022
Actual Study Start Date  ICMJE December 1, 2020
Actual Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2020)		 Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on ketamine [ Time Frame: up to 41 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
  • Spatial Working Memory (SWM) Between Errors (BE468) on ketamine [ Time Frame: up to 41 days ]
  • Rapid Visual Information Processing A' Prime (RVPA) on ketamine [ Time Frame: up to 41 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
3-treatment period design
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Lamotrigine
    Tablet
  • Drug: BI 409306
    Film-coated tablet
  • Drug: Placebo
    Tablet, Film-coated tablet
  • Drug: BI 425809
    Film-coated tablet
Study Arms  ICMJE
  • Experimental: Treatment sequence: T1-T2-R

    Treatments:

    T1: Lamotrigine T2: BI 409306 T3: BI 425809 R: Placebo

    Interventions:
    • Drug: Lamotrigine
    • Drug: BI 409306
    • Drug: Placebo
  • Experimental: Treatment sequence: T1-R-T2
    Interventions:
    • Drug: Lamotrigine
    • Drug: BI 409306
    • Drug: Placebo
  • Experimental: Treatment sequence: T1-T3-R
    Interventions:
    • Drug: Lamotrigine
    • Drug: Placebo
    • Drug: BI 425809
  • Experimental: Treatment sequence: T1-R-T3
    Interventions:
    • Drug: Lamotrigine
    • Drug: Placebo
    • Drug: BI 425809
  • Experimental: Treatment sequence: T2-T1-R
    Interventions:
    • Drug: Lamotrigine
    • Drug: BI 409306
    • Drug: Placebo
  • Experimental: Treatment sequence: T2-R-T1
    Interventions:
    • Drug: Lamotrigine
    • Drug: BI 409306
    • Drug: Placebo
  • Experimental: Treatment sequence: T2-T3-R
    Interventions:
    • Drug: BI 409306
    • Drug: Placebo
    • Drug: BI 425809
  • Experimental: Treatment sequence: T2-R-T3
    Interventions:
    • Drug: BI 409306
    • Drug: Placebo
    • Drug: BI 425809
  • Experimental: Treatment sequence: T3-R-T1
    Interventions:
    • Drug: Lamotrigine
    • Drug: Placebo
    • Drug: BI 425809
  • Experimental: Treatment sequence: T3-T1-R
    Interventions:
    • Drug: Lamotrigine
    • Drug: Placebo
    • Drug: BI 425809
  • Experimental: Treatment sequence: T3-T2-R
    Interventions:
    • Drug: BI 409306
    • Drug: Placebo
    • Drug: BI 425809
  • Experimental: Treatment sequence: T3-R-T2
    Interventions:
    • Drug: BI 409306
    • Drug: Placebo
    • Drug: BI 425809
  • Experimental: Treatment sequence: R-T1-T2
    Interventions:
    • Drug: Lamotrigine
    • Drug: BI 409306
    • Drug: Placebo
  • Experimental: Treatment sequence: R-T2-T1
    Interventions:
    • Drug: Lamotrigine
    • Drug: BI 409306
    • Drug: Placebo
  • Experimental: Treatment sequence: R-T1-T3
    Interventions:
    • Drug: Lamotrigine
    • Drug: Placebo
    • Drug: BI 425809
  • Experimental: Treatment sequence: R-T3-T1
    Interventions:
    • Drug: Lamotrigine
    • Drug: Placebo
    • Drug: BI 425809
  • Experimental: Treatment sequence: R-T2-T3
    Interventions:
    • Drug: BI 409306
    • Drug: Placebo
    • Drug: BI 425809
  • Experimental: Treatment sequence: R-T3-T2
    Interventions:
    • Drug: BI 409306
    • Drug: Placebo
    • Drug: BI 425809
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2022)		 39
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2020)		 36
Actual Study Completion Date  ICMJE August 12, 2022
Actual Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04602221
Other Study ID Numbers  ICMJE 1289-0057
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party Boehringer Ingelheim
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Boehringer Ingelheim
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP