A study in healthy Japanese men to test how well different doses of BI 764198 are tolerated

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)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071200055

Enrollment

Registered

2020-11-25

Start date

2021-01-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

IMP (BI 764198) administration and laboratory test etc.. Oral daily dose, once per day.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy male subjects, age of 20 to 45 years (inclusive), body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with drug-related adverse events	—

Secondary

Measure	Time frame
Pharmacokinetic parameters will be determined if feasible	—

Contacts

Public ContactYuji Takasu

Boehringer Ingelheim

ctinfo@boehringer-ingelheim.com+81-3-6417-2770

Outcome results