A Study in Healthy Japanese Men to Test How Well Different Doses of BI 1291583 Are Tolerated

Healthy Clinical Trial

Official title:

Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1291583 in Healthy Male Japanese Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05183347
• Other study ID #: 1397-0003
• Status: Completed
• Phase: Phase 1
• Start date: February 4, 2022
• Est. completion date: July 27, 2022

Study information

• Verified date: August 2022
• 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, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• 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)), 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, and have parents and grandparents who are Japanese
• Age of 20 to 45 years (inclusive) at screening visit
• BMI of 18.5 to 25.0 kilograms divided by height in meters squared (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, 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 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 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)
• Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT / QTc interval prolongation [QT: Time between start of the Q-wave and the end of the T-wave in an electrocardiogram, QTc: QT interval corrected for heart rate using the method of Fridericia (QTcF) or Bazett (QTcB)]
• Futher exclusion criteria apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1291583
BI 1291583
• 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	Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator		up to 65 days
Secondary	SRD: Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)	SRD: single-rising dose	up to 29 days
Secondary	SRD: Maximum measured concentration of BI 1291583 in plasma (Cmax)	SRD: single-rising dose	up to 29 days
Secondary	MD: After the first dose: Area under the concentration-time curve of BI 1291583 in plasma over a uniform dosing interval t (AUCt,1)	MD: multiple doses	up to 24 hours
Secondary	MD: After the first dose: Maximum measured concentration of BI 1291583 in plasma (Cmax,1)	MD: multiple doses	up to 24 hours
Secondary	MD: After the last dose: Area under the concentration-time curve of BI 1291583 in plasma at steady state over a uniform dosing interval t (AUCt,ss)	MD: multiple doses	at day 28
Secondary	MD: After the last dose: Maximum measured concentration of BI 1291583 in plasma at steady state (Cmax,ss)	MD: multiple doses	at day 28

External Links

•   Related Info