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

JRCT ID: jRCT2031230638

Registered date:16/02/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-alcoholic Steatohepatitis
• Date of first enrollment: 01/04/2024
• Target sample size: 36
• Study type: Interventional
• Intervention(s): Drug: BI 3006337 or Placebo, CALONAL Syrup 2%, TRELAN -G75

Outcome(s)

• Primary Outcome: The percentage of subjects with drug-related adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Narita Chie