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

NCT04602221 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 1289-0057
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on Ketamine

  Paired Associate Learning (PAL) assesses visual memory and new learning. Boxes are displayed on the screen and open in turn to reveal a number of patterns. Participants are instructed to try to remember the location in which each pattern was shown. After all the boxes have been opened, each pattern is then shown in the center of the screen in a randomised order, and the participant touches the box in which the pattern was located. If an error is made, all the patterns are re-presented to remind the participant of their locations. The PALTEA28 evaluates the number of errors committed by the subject plus an adjustment for the estimated number of errors they would have made on any stages that were not reached. Calculated across all assessed two, four, six and eight box trials.

  At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.

Secondary Outcomes (2)

• Spatial Working Memory (SWM) Between Errors (BE468) on Ketamine

  At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.

• Rapid Visual Information Processing A' Prime (RVPA) on Ketamine

  At 4:20 and 5:06 hours:minutes after first drug administration in each treatment period.

Study Arms (18)

Treatment sequence: T1-T2-R

EXPERIMENTAL

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

Drug: Lamotrigine; Drug: BI 409306; Drug: Placebo

Treatment sequence: T1-R-T2

EXPERIMENTAL

Drug: Lamotrigine; Drug: BI 409306; Drug: Placebo

Treatment sequence: T1-T3-R

EXPERIMENTAL

Drug: Lamotrigine; Drug: Placebo; Drug: BI 425809

Treatment sequence: T1-R-T3

EXPERIMENTAL

Drug: Lamotrigine; Drug: Placebo; Drug: BI 425809

Treatment sequence: T2-T1-R

EXPERIMENTAL

Drug: Lamotrigine; Drug: BI 409306; Drug: Placebo

Treatment sequence: T2-R-T1

EXPERIMENTAL

Drug: Lamotrigine; Drug: BI 409306; Drug: Placebo

Treatment sequence: T2-T3-R

EXPERIMENTAL

Drug: BI 409306; Drug: Placebo; Drug: BI 425809

Treatment sequence: T2-R-T3

EXPERIMENTAL

Drug: BI 409306; Drug: Placebo; Drug: BI 425809

Treatment sequence: T3-R-T1

EXPERIMENTAL

Drug: Lamotrigine; Drug: Placebo; Drug: BI 425809

Treatment sequence: T3-T1-R

EXPERIMENTAL

Drug: Lamotrigine; Drug: Placebo; Drug: BI 425809

Treatment sequence: T3-T2-R

EXPERIMENTAL

Drug: BI 409306; Drug: Placebo; Drug: BI 425809

Treatment sequence: T3-R-T2

EXPERIMENTAL

Drug: BI 409306; Drug: Placebo; Drug: BI 425809

Treatment sequence: R-T1-T2

EXPERIMENTAL

Drug: Lamotrigine; Drug: BI 409306; Drug: Placebo

Treatment sequence: R-T2-T1

EXPERIMENTAL

Drug: Lamotrigine; Drug: BI 409306; Drug: Placebo

Treatment sequence: R-T1-T3

EXPERIMENTAL

Drug: Lamotrigine; Drug: Placebo; Drug: BI 425809

Treatment sequence: R-T3-T1

EXPERIMENTAL

Drug: Lamotrigine; Drug: Placebo; Drug: BI 425809

Treatment sequence: R-T2-T3

EXPERIMENTAL

Drug: BI 409306; Drug: Placebo; Drug: BI 425809

Treatment sequence: R-T3-T2

EXPERIMENTAL

Drug: BI 409306; Drug: Placebo; Drug: BI 425809

Interventions

Lamotrigine DRUG

Tablet

Treatment sequence: R-T1-T2; Treatment sequence: R-T1-T3; Treatment sequence: R-T2-T1; Treatment sequence: R-T3-T1; Treatment sequence: T1-R-T2; Treatment sequence: T1-R-T3; Treatment sequence: T1-T2-R; Treatment sequence: T1-T3-R; Treatment sequence: T2-R-T1; Treatment sequence: T2-T1-R; Treatment sequence: T3-R-T1; Treatment sequence: T3-T1-R

BI 409306 DRUG

Film-coated tablet

Treatment sequence: R-T1-T2; Treatment sequence: R-T2-T1; Treatment sequence: R-T2-T3; Treatment sequence: R-T3-T2; Treatment sequence: T1-R-T2; Treatment sequence: T1-T2-R; Treatment sequence: T2-R-T1; Treatment sequence: T2-R-T3; Treatment sequence: T2-T1-R; Treatment sequence: T2-T3-R; Treatment sequence: T3-R-T2; Treatment sequence: T3-T2-R

Placebo DRUG

Tablet, Film-coated tablet

Treatment sequence: R-T1-T2; Treatment sequence: R-T1-T3; Treatment sequence: R-T2-T1; Treatment sequence: R-T2-T3; Treatment sequence: R-T3-T1; Treatment sequence: R-T3-T2; Treatment sequence: T1-R-T2; Treatment sequence: T1-R-T3; Treatment sequence: T1-T2-R; Treatment sequence: T1-T3-R; Treatment sequence: T2-R-T1; Treatment sequence: T2-R-T3; Treatment sequence: T2-T1-R; Treatment sequence: T2-T3-R; Treatment sequence: T3-R-T1; Treatment sequence: T3-R-T2; Treatment sequence: T3-T1-R; Treatment sequence: T3-T2-R

BI 425809 DRUG

Film-coated tablet

Treatment sequence: R-T1-T3; Treatment sequence: R-T2-T3; Treatment sequence: R-T3-T1; Treatment sequence: R-T3-T2; Treatment sequence: T1-R-T3; Treatment sequence: T1-T3-R; Treatment sequence: T2-R-T3; Treatment sequence: T2-T3-R; Treatment sequence: T3-R-T1; Treatment sequence: T3-R-T2; Treatment sequence: T3-T1-R; Treatment sequence: T3-T2-R

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age of 18 to 55 years (inclusive)
• BMI of 18.5 to 32 kg/m2 (inclusive)
• Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
• 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

You may not qualify if:

• Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator
• 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
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

Collaborative Neuroscience Research, LLC

Long Beach, California, 90806, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

Lamotrigine; BI 409306; BI 425809

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

18002430127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3-treatment period design

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 26, 2020
• Study Start: December 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 12, 2022
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)