A study in healthy Japanese men to test how different doses of BI 690517 are taken up in the body and how well they are tolerated

Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising oral doses of BI 690517 in healthy Japanese male subjects (double-blind, randomised, placebo-controlled within dose groups)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224000

Enrollment

Registered

2018-08-06

Start date

2018-08-06

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

investigational material(s) Generic name etc : BI 690517 INN of investigational material : - Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigational m

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy male Japanese subjects, age of 20 to 50 years, body mass index (BMI) of 18.5 to 25.0 kg/m2

Exclusion criteria

Exclusion criteria: 1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 100 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

Design outcomes

Primary

Measure	Time frame
safety safety, tolerability, pharmacokinetics	—

Secondary

Measure	Time frame
safety pharmacokinetics safety, tolerability, pharmacokinetics	—

Countries

Japan

Outcome results