A Study in Healthy Men to Test How BI 764198 is Processed in the Body

Healthy Clinical Trial

Official title:

A Phase I, Open-label, Two-arm, Non-randomised Trial to Investigate the Metabolism and Pharmacokinetics of a Single Dose of BI 764198 (C-14) Administered as Oral Solution Using Two Different Approaches in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05863130
• Other study ID #: 1434-0016
• Status: Completed
• Phase: Phase 1
• Start date: May 3, 2023
• Est. completion date: November 9, 2023

Study information

• Verified date: November 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this trial is to investigate the basic pharmacokinetics of BI 764198 and its metabolites, total radioactivity including mass balance, excretion pathways and metabolism following oral administration to healthy male volunteers of a single oral dose of BI 764198 (C-14) in i) a classical hADME approach and ii) a hADME microtracer approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ElectroCardioGram (ECG), and clinical laboratory tests

• Age of 18 to 65 years (inclusive)

• BMI of 18.5 to 29.9 kg/m2 (inclusive)

• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

• 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

• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

• Any evidence of a concomitant disease assessed as clinically relevant by the investigator

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders Further exclusion criteria apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 764198 (C-14) (approach 1)
BI 764198 (C-14) (approach 1)
• BI 764198 (C-14) (approach 2)
BI 764198 (C-14) (approach 2)

Locations

Country	Name	City	State
Netherlands	ICON	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine,0-tz)		Up to 31 days
Primary	Fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces,0-tz)		Up to 31 days
Secondary	Maximum measured concentration of the analyte in plasma (Cmax)		Up to 31 days
Secondary	Area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable data point) in plasma (AUC0-tz)		Up to 31 days

External Links

•   Related Info