A phase I, open-label trial to investigate metabolism, pharmacokinetics (following a mass balance design) and absolute bioavailability of BI 690517 (C-14) after oral and intravenous administration in healthy male subjects

Completed

Conditions: chronic kidney disease
10038430

Registration Number: NL-OMON51347

Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

1. Healthy male subjects according to the assessment of the investigator, as
based on a complete medical history
including a physical examination, vital signs (BP, PR), 12-lead ECG, and
clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. BMI of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and
local legislation prior to admission
to the trial

Exclusion Criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating
from normal and assessed as
clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to
140 mmHg, diastolic blood
pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of
40 to 100 bpm
3. Any laboratory value outside the reference range that the investigator
considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the
investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders

Further criteria apply

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part A<br /><br>- Mass balance recovery of [14C] radioactivity in urine and feces after oral<br /><br>administration of BI 690517 (C-14): amount of radioactivity<br /><br>excreted as a percentage of the administered dose for urine and feces over the<br /><br>time interval from 0 to the last quantifiable time point, feurine,0-tz and<br /><br>fefeces, 0-tz<br /><br><br /><br>Part B<br /><br>- AUC0-* of [14C] BI 690517 (i.v.) and BI 690517 (oral)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part A<br /><br>- AUC0-tz and Cmax of [14C] radioactivity and BI 690517 in plasma<br /><br><br /><br>Part B<br /><br>AUC0-tz and Cmax of [14C] BI 690517 (i.v.) and BI 690517 (oral) in plasma</p><br>