NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-184059

Registered date:06/08/2018

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

Basic Information

Recruitment status complete
Health condition(s) or Problem(s) studied-
Date of first enrollment06/8/2018
Target sample size36
Countries of recruitmentJapan
Study typeINTERVENTIONAL
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 Outcomesafety safety, tolerability, pharmacokinetics
Secondary Outcomesafety, pharmacokinetics safety, tolerability, pharmacokinetics

Key inclusion & exclusion criteria

Age minimum20
Age maximum50
GenderMale
Include criteriaHealthy male Japanese subjects, age of 20 to 50 years, body mass index (BMI) of 18.5 to 25.0 kg/m2
Exclude criteria1. 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

Contact

public contact
Name Nippon boehringer ingelheim Clinical operations japan
Address https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B
Telephone
E-mail
Affiliation
scientific contact
Name Nippon boehringer ingelheim Clinical operations japan
Address https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B
Telephone
E-mail
Affiliation