MedTrace Logo

A Study in Healthy Men to Test How BI 730357 is Processed by the Body

NCT03664011 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-07-12

Study results available
· View outcomes & findings →

Summary

The main objectives of the study are as follows:

* To assess the mass balance recovery of (C-14) BI 730357-radioactivity (also expressed as 14C-BI 730357-EQ) in urine and faeces after a single oral dose of 50 mg BI 730357 base (BS) (C-14) in healthy male subjects
* To provide plasma, urine, and faecal samples for metabolite profiling and structural identification

Conditions

  • Healthy

Interventions

DRUG

BI 730357 mixed with [C-14]BI 730357 BS

Oral Solution

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2018-11-13
Completion
2018-11-13

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 NCT03664011 on ClinicalTrials.gov