A Study in Healthy Men to Test How Well Different Doses of BI 1839100 Are Tolerated (1490-0003)

NCT05934955 | Completed Phase 1

• 1 other identifier: 1490-0003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1839100 in healthy male subjects following oral administration of single rising doses.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

  up to 10 days

Secondary Outcomes (2)

• Area under the concentration-time curve of plasma BI 1839100 over the time interval from 0 extrapolated to infinity (AUC0-∞)

  up to 4 days

• Maximum measured concentration of BI 1839100 in plasma (Cmax)

  up to 4 days

Study Arms (4)

BI 1839100 low dose

EXPERIMENTAL

Drug: BI 1839100

BI 1839100 medium dose

EXPERIMENTAL

Drug: BI 1839100

BI 1839100 high dose

EXPERIMENTAL

Drug: BI 1839100

Placebo

PLACEBO COMPARATOR

Drug: Placebo matching BI 1839100

Interventions

BI 1839100 DRUG

BI 1839100

BI 1839100 high dose; BI 1839100 low dose; BI 1839100 medium dose

Placebo matching BI 1839100 DRUG

Placebo matching BI 1839100

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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 kg/m2 (inclusive)
• 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 start of trial medication until 90 days after end 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

You may not qualify if:

• 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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 40 to 99 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, 130-0004, Japan

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: July 13, 2023
• Primary Completion: September 25, 2023
• Study Completion: October 2, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)