CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167, Germany
NCT Number: NCT03100916
The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy male subjects following oral administration of multiple rising doses over 14 days (MRD part).
Secondary objectives for the MRD part are the exploration of PK (Pharmacokinetic(s)), including dose proportionality, as well as investigation of linearity and PD (Pharmacodynamic(s)) of BI 690517 after multiple dosing.
For the FE (food effect) part, the secondary objective is to investigate the relative bioavailability of BI 690517 under fasted conditions (Reference, R) compared to BI 690517 (single dose) after a high fat high caloric breakfast (Test, T).
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Notify Me18 year–50 year
Male
Interventional
Phase 1
Mannheim, 68167, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
once daily
Other names: Vicadrostat
once daily
Fasting
Other names: Vicadrostat
Time frame: Day 30
[N (%)] of subjects with drug-related Adverse Events
Time frame: 0-24 hours
AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose [AUCtau,1 will be AUC0-24])
Time frame: up to 24 hours
Cmax (maximum measured concentration of the analyte in plasma) (After the first dose)(Multiple rising dose part)
Time frame: 312 - 360 hours
AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau)(After the last dose)(Multiple rising dose part)
Time frame: after 312 hours and up to 360 hours
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau)(After the last dose)(Multiple rising dose part)
Time frame: Up to 48 hours
Cmax (maximum measured concentration of the analyte in plasma) (Food effect part)
Time frame: Up to 48 hours
AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 48 hours
AUC0- tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Boehringer Ingelheim
Industry
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 690517 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Within Dose Groups) and Effect of Food on the Bioavailability of BI 690517 (Openlabel, Randomised, Two-way Cross-over)
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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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