A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated

Healthy Clinical Trial

Official title:

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1569912 in Healthy Male Japanese Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel-group Design)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04958252
• Other study ID #: 1447-0004
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 5, 2021
• Est. completion date: October 24, 2023

Study information

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

Clinical Trial Summary

The main objectives of this trial are to investigate safety and tolerability of BI 1569912 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.

Secondary objective is the exploration of pharmacokinetics (PK) of BI 1569912.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: October 24, 2023
• Est. primary completion date: October 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 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 medical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests

• Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese

• Age of 18 to 45 years (inclusive)

• Body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)

• 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, 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

• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 to 99 beats per minute (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)

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1569912
BI 1569912
• Placebo
Placebo

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	Part A and Part B: Percentage of subjects with drug-related adverse events		up to 27 days
Primary	Part C: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)		up to 3 days
Primary	Part C: Maximum measured concentration of the analyte in plasma (Cmax)		up to 3 days
Secondary	Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 4 days
Secondary	Part A: Maximum measured concentration of the analyte in plasma (Cmax)		up to 4 days
Secondary	Part B, after the first dose: Area under the concentration-time curve of the analyte in plasma from 0 to 24 hours (AUC0-24)		up to 17 days
Secondary	Part B, after the first dose: Maximum measured concentration of the analyte in plasma (Cmax)		up to 17 days
Secondary	Part B, after the last dose: Area under the concentration-time curve of the analyte in plasma over the dosing interval t at steady state (AUCt,ss)		up to 17 days
Secondary	Part B, after the last dose: Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)		up to 17 days
Secondary	Part C: Percentage of subjects with drug-related adverse events		up to 3 days
Secondary	Part C: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 3 days

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