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

NCT05863130 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-11-15

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

BI 764198 (C-14) (approach 1)

BI 764198 (C-14) (approach 1)

DRUG

BI 764198 (C-14) (approach 2)

BI 764198 (C-14) (approach 2)

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-03
Primary Completion
2023-11-09
Completion
2023-11-09

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05863130 on ClinicalTrials.gov