A Study in Healthy Men to Test Whether BI 474121 Can Reverse the Memory Problems Caused by Ketamine

Boehringer Ingelheim

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI 474121; Drug: Ketamine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT05451095

1411-0003

Details and patient eligibility

About

To investigate the effect of BI 474121 compared to placebo on ketamine-induced cognitive deficits to predict efficacy in patients with cognitive disorders.

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (inclusive)
• Body mass index (BMI) of 18.5 to 32 kg/m2 (inclusive)
• Signed and dated written informed consent(s) prior to admission to the study, in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• If men who are able to father a child, are willing to participate, they have to use an adequate form of effective contraception for the duration of study participation and for at least 30 days after treatment has ended

Exclusion criteria

• 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 90 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 evaluated as clinically significant by Investigators
• 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
• History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 6 patient groups

Treatment sequence T1-T2-R

Experimental group

Description:

T1: Lower dose of BI 474121 and higher dose of placebo followed by intravenous ketamine infusion T2: Higher dose of BI 474121 and lower dose of placebo followed by intravenous ketamine infusion R: Lower dose of placebo and higher dose of placebo followed by intravenous ketamine infusion

Treatment:

Drug: Placebo

Drug: Ketamine hydrochloride

Drug: BI 474121

Treatment sequence T2-T1-R

Experimental group

Treatment:

Drug: Placebo

Drug: Ketamine hydrochloride

Drug: BI 474121

Treatment sequence T1-R-T2

Experimental group

Treatment:

Drug: Placebo

Drug: Ketamine hydrochloride

Drug: BI 474121

Treatment sequence T2-R-T1

Experimental group

Treatment:

Drug: Placebo

Drug: Ketamine hydrochloride

Drug: BI 474121

Treatment sequence R-T1-T2

Experimental group

Treatment:

Drug: Placebo

Drug: Ketamine hydrochloride

Drug: BI 474121

Treatment sequence R-T2-T1

Experimental group

Treatment:

Drug: Placebo

Drug: Ketamine hydrochloride

Drug: BI 474121