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

JAPIC ID: JapicCTI-184059

Registered date:06/08/2018

Basic Information

• Recruitment status: complete
• Health condition(s) or Problem(s) studied: -
• Date of first enrollment: 06/8/2018
• Target sample size: 36
• Countries of recruitment: Japan
• Study type: INTERVENTIONAL

Intervention(s)

Intervention name : BI 690517
INN of the intervention : -
Dosage And administration of the intervention : Oral
Control intervention name : placebo
INN of the control intervention : -
Dosage And administration of the control intervention : oral administraion

Outcome(s)

Primary Outcome

safety
safety, tolerability, pharmacokinetics

Secondary Outcome

safety, pharmacokinetics
safety, tolerability, pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: 20
• Age maximum: 50
• Gender: Male

Include criteria

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

Exclude 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

Related Information

• Primary Sponsor: Nippon boehringer ingelheim
• Secondary Sponsor: -
• Source(s) of Monetary Support: -