Safety, tolerability, and pharmacokinetics of single rising oral doses of BI 1839100 in healthy male subjects (single-blind, randomised, placebo-controlled, parallel group design)

JRCT ID: jRCT2071230027

Registered date:25/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: -
• Date of first enrollment: 25/06/2023
• Target sample size: 24
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : BI 1839100
INN of investigational material : -
Therapeutic category code : 399 Other agents affecting metabolism
Dosage and Administration for Investigational material : 20 mg
Oral with 240 mL of water

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Not applicable
Oral with 240 mL of water

Outcome(s)

Primary Outcome

safety
The percentage (%) of subjects with drug related adverse events

Secondary Outcome

pharmacokinetics
Cmax, AUC0 of BI 1839100

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 physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
2. 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
3. Age of 18 to 45 years (inclusive)
4. BMI of 18.5 to 25 kg/m2 (inclusive)
5. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
6. 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 subjects female partner

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 99 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
8. History of relevant orthostatic hypotension, fainting spells, or blackouts
9. Relevant chronic or acute infections
10. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin
11. History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
12. Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
13. Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
14. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
15. Inability to refrain from smoking on specified trial days
16. Alcohol abuse (consumption of more than 24 g per day for males)
17. Drug abuse or positive drug screening
18. Blood donation of more than 400 mL within 12 weeks or 200 mL within 30 days or
plasma donation within 2 weeks prior to administration of trial medication or intended blood donation during the trial
19. Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
20. Inability to comply with the dietary regimen of the trial site
21. A marked prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or any other relevant ECG finding at screening
22. A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)
23. Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
24. History of disease that affects the present situation
25. During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection
26. Positive result for human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, and syphilis infection at screening.

Related Information

• Primary Sponsor: - -