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

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 - Study to test how BI 690517 is taken up and handled by the body

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51347

Enrollment

Registered

2022-08-23

Start date

2022-09-23

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic kidney disease

Interventions

In Part A the volunteer will receive a single dose of 20 milligrams radioactively labeled BI 690517(C-14) (oral solution). In Part B the volunteer will first receive a single dose of 20 milligrams

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Part A - AUC0-tz and Cmax of [14C] radioactivity and BI 690517 in plasma Part B AUC0-tz and Cmax of [14C] BI 690517 (i.v.) and BI 690517 (oral) in plasma	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)