A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated

Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 1819479 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

This is a study to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1819479 in healthy male Japanese subjects receiving single rising doses (SRD) in order to provide the basis for a clinical development of BI 1819479 in Japan.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Matching placebo; Drug: BI 1819479

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Sumida-ku, Japan, 130-0004
    • SOUSEIKAI Sumida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 18 to 45 years (inclusive) at screening visit
• Body mass index (BMI) of 18.5 to 24.9 kg/m2 (inclusive) at screening visit
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

• Subjects who agree to minimise the risk of making their partner pregnant by fulfilling any of the following criteria starting from the admission to trial site until 90 days after 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.
  • Female partner is postmenopausal, defined as no menses for 1 year without an alternative medical cause.

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 BP outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic BP outside the range of 40 to 90 mmHg, or PR outside the range of 40 to 99 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Matching placebo; Matching placebo
Experimental: Dose Group 1: BI 1819479 (Low dose)	Drug: BI 1819479; BI 1819479
Experimental: Dose Group 2: BI 1819479 (Middle dose)	Drug: BI 1819479; BI 1819479
Experimental: Dose Group 3: BI 1819479 (High Dose)	Drug: BI 1819479; BI 1819479

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients treated who experience treatment-emergent adverse event assessed as drug-related by the investigator	Up to 64 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve of BI 1819479 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to 31 Days
Maximum measured concentration of BI 1819479 in plasma (Cmax)	Up to 31 Days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1462-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD 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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No