臨床研究等提出・公開システム

Safety, tolerability, and pharmacokinetics of single rising oral dose and multiple rising oral doses of BI 706321 in healthy Japanese male subjects and single oral dose of BI 706321 in healthy Chinese male subjects (double-blind, randomised, placebo-controlled, parallel group design)

A study in healthy Japanese and Chinese men to test how well different doses of BI 706321 are tolerated

Umezu Masafumi

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Yamagami Tomohiro

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Suspended

Feb. 05, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Healthy male subjects according to the assessment of the investigator, as based on a
complete medical history including a medical examination, vital signs (BP, PR), 12-lead
ECG, and clinical laboratory tests
Japanese (Part I) or Chinese (Part II)ethnicity
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 GCP and local legislation

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 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

Male

Crohns disease

Drug: BI 706321
Other: Placebo

The percentage of subjects with drug-related adverse events

+81-92-283-7701

Jan. 17, 2022

Yes

Researchers can refer to https://trials.boehringer-ingelheim.com/ to request access to raw data from our clinical studies.

none