A Phase 1 interventional study of BI 705564 and Placebo in Healthy, sponsored by Boehringer Ingelheim. Withdrawn. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-15.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
The primary objective of this trial is to investigate the safety and tolerability of BI 705564 in healthy male subjects following oral administration of single rising doses.
A secondary objective is the exploration of the PK including dose proportionality of BI 705564 after single dosing.
Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male subject who agree to minimize the risk of female partners becoming pregnant by fulfilling any of the following criteria starting from at least 30 days before the first administration of trial medication and until 90 days after the trial completion:
Use of adequate contraception, e.g., any of the following methods plus condom:
--- combined oral contraceptives, intrauterine device.
Exclusion criteria:
Drug: BI 705564
Drug: Placebo
single-rising oral dose
single-rising oral dose
Number [N (%)] of subjects with drug-related Adverse Events (AEs)
Time frame: Up to day 7
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 72 hours
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 72 hours
No study locations are listed for this record.
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boehringer Ingelheim