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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT04602221
Collaborator
(none)
39
2
18
20.3
19.5
1

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
3-treatment period design3-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 :
Dec 1, 2020
Actual Primary Completion Date :
Aug 1, 2022
Actual Study Completion Date :
Aug 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment sequence: T1-T2-R

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

Drug: Lamotrigine
Tablet

Drug: BI 409306
Film-coated tablet

Drug: Placebo
Tablet, Film-coated tablet

Experimental: Treatment sequence: T1-R-T2

Drug: Lamotrigine
Tablet

Drug: BI 409306
Film-coated tablet

Drug: Placebo
Tablet, Film-coated tablet

Experimental: Treatment sequence: T1-T3-R

Drug: Lamotrigine
Tablet

Drug: Placebo
Tablet, Film-coated tablet

Drug: BI 425809
Film-coated tablet

Experimental: Treatment sequence: T1-R-T3

Drug: Lamotrigine
Tablet

Drug: Placebo
Tablet, Film-coated tablet

Drug: BI 425809
Film-coated tablet

Experimental: Treatment sequence: T2-T1-R

Drug: Lamotrigine
Tablet

Drug: BI 409306
Film-coated tablet

Drug: Placebo
Tablet, Film-coated tablet

Experimental: Treatment sequence: T2-R-T1

Drug: Lamotrigine
Tablet

Drug: BI 409306
Film-coated tablet

Drug: Placebo
Tablet, Film-coated tablet

Experimental: Treatment sequence: T2-T3-R

Drug: BI 409306
Film-coated tablet

Drug: Placebo
Tablet, Film-coated tablet

Drug: BI 425809
Film-coated tablet

Experimental: Treatment sequence: T2-R-T3

Drug: BI 409306
Film-coated tablet

Drug: Placebo
Tablet, Film-coated tablet

Drug: BI 425809
Film-coated tablet

Experimental: Treatment sequence: T3-R-T1

Drug: Lamotrigine
Tablet

Drug: Placebo
Tablet, Film-coated tablet

Drug: BI 425809
Film-coated tablet

Experimental: Treatment sequence: T3-T1-R

Drug: Lamotrigine
Tablet

Drug: Placebo
Tablet, Film-coated tablet

Drug: BI 425809
Film-coated tablet

Experimental: Treatment sequence: T3-T2-R

Drug: BI 409306
Film-coated tablet

Drug: Placebo
Tablet, Film-coated tablet

Drug: BI 425809
Film-coated tablet

Experimental: Treatment sequence: T3-R-T2

Drug: BI 409306
Film-coated tablet

Drug: Placebo
Tablet, Film-coated tablet

Drug: BI 425809
Film-coated tablet

Experimental: Treatment sequence: R-T1-T2

Drug: Lamotrigine
Tablet

Drug: BI 409306
Film-coated tablet

Drug: Placebo
Tablet, Film-coated tablet

Experimental: Treatment sequence: R-T2-T1

Drug: Lamotrigine
Tablet

Drug: BI 409306
Film-coated tablet

Drug: Placebo
Tablet, Film-coated tablet

Experimental: Treatment sequence: R-T1-T3

Drug: Lamotrigine
Tablet

Drug: Placebo
Tablet, Film-coated tablet

Drug: BI 425809
Film-coated tablet

Experimental: Treatment sequence: R-T3-T1

Drug: Lamotrigine
Tablet

Drug: Placebo
Tablet, Film-coated tablet

Drug: BI 425809
Film-coated tablet

Experimental: Treatment sequence: R-T2-T3

Drug: BI 409306
Film-coated tablet

Drug: Placebo
Tablet, Film-coated tablet

Drug: BI 425809
Film-coated tablet

Experimental: Treatment sequence: R-T3-T2

Drug: BI 409306
Film-coated tablet

Drug: Placebo
Tablet, Film-coated tablet

Drug: BI 425809
Film-coated tablet

Outcome Measures

Primary Outcome Measures

  1. Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on ketamine [up to 41 days]

Secondary Outcome Measures

  1. Spatial Working Memory (SWM) Between Errors (BE468) on ketamine [up to 41 days]

  2. Rapid Visual Information Processing A' Prime (RVPA) on ketamine [up to 41 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Collaborative Neuroscience Research, LLC Long Beach California United States 90806
2 Hassman Research Institute Marlton New Jersey United States 08053

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04602221
Other Study ID Numbers:
  • 1289-0057
First Posted:
Oct 26, 2020
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022