MedTrace Logo

A Study in Healthy Men to Test How BI 685509 is Processed in the Body

NCT05515328 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-11-28

No results posted yet for this study

Summary

The main objective of Part A is to investigate basic pharmacokinetics of BI 685509 and total radioactivity, including mass balance, excretion pathways and metabolism following administration of BI 685509 to healthy male subjects.

The main objective of Part B is to determine the absolute bioavailability of BI 685509 after administration to healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

[¹⁴C] BI 685509 formulation 1

\[¹⁴C\] BI 685509 formulation 1

DRUG

[¹⁴C] BI 685509 formulation 2

\[¹⁴C\] BI 685509 formulation 2

DRUG

BI 685509 formulation 3

BI 685509 formulation 3

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2022-11-17
Completion
2022-11-17

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT05515328 on ClinicalTrials.gov