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Completed

NCT Number: NCT04665700

A Study in Healthy Japanese Men to Test How Well Different Doses of BI 764198 Are Tolerated

The main objectives of this trial are to investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of single dose and multiple rising doses per day over 14 days.

Secondary objectives are the exploration of pharmacokinetics (PK) of BI 764198 after single and multiple oral dosing.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, 130-0004, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 (BP, PR), 12-lead 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 20 to 45 years at screening (inclusive)
  • BMI of 18.5 to 25.0 kg/m2 (inclusive)
  • Signed and dated written informed consent prior to admission to the trial, in accordance with GCP and local legislation
  • Willingness to comply with contraception requirements. Subjects who are sexually active must use adequate contraception methods throughout the trial and until three months after the last administration of trial medication. Adequate methods are:
  • A vasectomy performed at least 1 year prior to screening and with medical assessment of the surgical success or
  • Surgical sterilisation, including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy, of the subject's female partner or
  • The use of condoms, if the female partner uses an adequate contraception method in addition, e.g., intrauterine device (IUD), or hormonal contraception, such as implants and injectables*, combined with oral or vaginal contraceptives, that started at least 2 months prior to first drug administration, or barrier method, e.g., diaphragm with spermicide* * hormonal contraception via implants and injectables, and diaphragm with spermicide are not approved in Japan Unprotected sexual intercourse with a pregnant partner is not allowed throughout the trial and until three months after the last administration of trial medication.

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 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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.

Treatment and study plan

BI 764198

Drug

BI 764198

Placebo

Drug

Placebo

Primary outcomes

  1. The percentage [%] of subjects with drug-related adverse events

    Time frame: Up to 34 days

Secondary outcomes

  1. After single dose: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: Up to 6 days

  2. After single dose: Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: Up to 6 days

  3. After the last dose of multiple dose segment: AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)

    Time frame: Up to 22 days

  4. After the last dose of multiple dose segment: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

    Time frame: Up to 22 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability and Pharmacokinetics of Single and Multiple Rising Doses of BI 764198 in Japanese Healthy Male Subjects (Double-blind, Randomised, Placebo-controlled Within Dose Groups, Parallel Group Design)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 14, 2020
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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