臨床研究等提出・公開システム

Safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising subcutaneous doses and multiple subcutaneous doses over 6 weeks of BI 3006337 in healthy male Japanese subjects (single-blind, randomised within dose groups, placebo-controlled, parallel group design)

A study in healthy Japanese men to test how well different doses of BI 3006337 are tolerated

Narita Chie

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

Not Recruiting

April. 01, 2024

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

1. 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
2. Japanese ethnicity
3. BMI of 18.5 to 25.0 kg/m2 (inclusive)
4. Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. 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
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. 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

Non-alcoholic Steatohepatitis

Drug: BI 3006337 or Placebo, CALONAL Syrup 2%, TRELAN -G75

The percentage of subjects with drug-related adverse events

+81-3-5213-0028

No

none