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

• ClinicalTrials.gov Identifier: NCT04602221
• Recruitment Status: Recruiting
• First Posted: October 26, 2020
• Last Update Posted: January 12, 2021
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: October 16, 2020
• First Posted Date: October 26, 2020
• Last Update Posted Date: January 12, 2021
• Actual Study Start Date: December 1, 2020
• Estimated Primary Completion Date: April 15, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 20, 2020): Paired Associate Learning (PAL) Total Errors Adjusted (PALTEA28) on ketamine [ Time Frame: up to 41 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
• 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
• 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: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

3-treatment period design

Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

• Condition: Healthy

Intervention

• Drug: Lamotrigine
  Tablet
• Drug: BI 409306
  Film-coated tablet
• Drug: Placebo
  Tablet, Film-coated tablet
• Drug: BI 425809
  Film-coated tablet

Study Arms

• Experimental: Lamotrigine treatment (T1)
  Intervention: Drug: Lamotrigine
• Experimental: BI 409306 treatment (T2)
  Intervention: Drug: BI 409306
• Placebo Comparator: Placebo treatment (R)
  Intervention: Drug: Placebo
• Experimental: BI 425809 treatment (T3)
  Intervention: Drug: BI 425809

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 20, 2020): 36
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 15, 2021
• Estimated Primary Completion Date: April 15, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04602221
• Other Study ID Numbers: 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

• 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: http://trials.boehringer-ingelheim.com/

• Responsible Party: Boehringer Ingelheim
• Study Sponsor: Boehringer Ingelheim
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Boehringer Ingelheim
• Verification Date: January 2021