A Study in Healthy Men to Test How BI 474121 is Tolerated

Healthy Clinical Trial

Official title:

Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 474121 in Healthy Japanese Male Subjects (Doubleblind, Randomised, Placebo-controlled, Parallel Group Design)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964453
• Other study ID #: 1411-0012
• Status: Completed
• Phase: Phase 1
• Start date: July 21, 2021
• Est. completion date: November 16, 2021

Study information

• Verified date: July 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety, tolerability, and pharmacokinetics of BI 474121 will be assessed in healthy Japanese male using single rising oral doses in order to provide the basis for an ongoing clinical development of BI 474121 for the treatment of cognitive impairment in patients with Alzheimer's Disease and schizophrenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 16, 2021
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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)) including body temperature, 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening visit

• Japanese ethnicity, according to the following criteria:

• born in Japan, have lived outside of Japan <10 years,

• have parents and grandparents who are Japanese

• Age of 20 to 45 years (inclusive) at screening visit

• Body mass index (BMI) of 18.5 to 25.0 kilogram per square meter (kg/m2) (inclusive) at screening visit

• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

• Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication

• Use of adequate contraception by any of the following methods plus condom:

intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration.

• Vasectomized (vasectomy at least 1 year prior to enrolment)

• Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner.

Exclusion Criteria:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit

• Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 millimetre of mercury (mmHg), or pulse rate outside the range of 50 to 90 beats per minute (bpm) at screening visit

• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit

• Any evidence of a concomitant disease assessed as clinically relevant by the investigator

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

• Chronic or relevant acute infections including viral hepatitis, human immunodeficiency virus (HIV) and/or syphilis.

• History of 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 relevant orthostatic hypotension, fainting spells, or blackouts

• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)

• further exclusion criteria apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Placebo
Healthy subjects were given a single dose of placebo tablet(s) matched to the active treatment, subjects receiving placebo were equally distributed across dose groups. Tablet(s) were taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
• BI 474121
Healthy subjects were given a single dose of BI 474121 as a uncoated tablet(s) taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.

Locations

Country	Name	City	State
Japan	SOUSEIKAI Sumida Hospital	Tokyo, Sumida-ku

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Drug-related Adverse Events (AEs)	Percentage of subjects with investigator-defined drug-related adverse events (AEs).	From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days.
Secondary	Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-8)	Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 extrapolated to infinity (AUC0-8).	Within 3 hours before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following drug administration.
Secondary	Maximum Measured Concentration of BI 474121 in Plasma (Cmax)	Maximum measured concentration of BI 474121 in plasma (Cmax).	Within 3 hours before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following drug administration.

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