SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, 130-0004, Japan
NCT Number: NCT03608072
The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy Japanese male subjects following oral administration of multiple rising doses over 14 days.
Secondary objective is the exploration of the pharmacokinetic(s) (PK) and pharmacodynamic(s) (PD) of BI 690517 in healthy Japanese male subjects after multiple dosing.
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Notify Me20 year–50 year
Male
Interventional
Phase 1
Tokyo, Sumida-ku, 130-0004, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-- born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
--- combined oral contraceptives, intrauterine device
Exclusion criteria
3 sequential dose groups
Other names: Vicadrostat
3 sequential dose groups
Time frame: Up to day 19
Time frame: up to 24 hours
Time frame: Up to 24 hours
Time frame: After 312 hours and up to 360 hours
Time frame: After 312 hours and up to 360 hours
Boehringer Ingelheim
Industry
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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