A Study in Healthy Men Tests How Different Doses of BI 764198 Are Taken up in the Body and How Well They Are Tolerated.
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|ClinicalTrials.gov Identifier: NCT03854552|
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : April 4, 2019
The main objective of this trial is to investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of single rising doses.
Secondary objectives are the exploration of pharmacokinetics (PK) including dose proportionality of BI 764198 after single oral dosing.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: BI 764198 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 764198 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled, Parallel Group Design)|
|Actual Study Start Date :||March 15, 2019|
|Estimated Primary Completion Date :||August 7, 2019|
|Estimated Study Completion Date :||August 7, 2019|
Experimental: BI 764198
Single rising oral doses
Drug: BI 764198
Placebo Comparator: Placebo
Single rising oral doses
- Percentage of subjects with drug-related adverse events. [ Time Frame: Up to Day 14 ]
- 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 168 hours ]
- Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 168 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854552
|Contact: Boehringer Ingelheimemail@example.com|
|CRS Clinical Research Services Mannheim GmbH||Recruiting|
|Mannheim, Germany, 68167|
|Contact: Helen Basse +49 (621) 15045130 firstname.lastname@example.org|