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A Study in Healthy Men to Test How BI 1265162 is Taken up and Processed by the Body

NCT04267276 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-06-01

Study results available
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Summary

To investigate rates and routes of excretion, mass balance, pharmacokinetics of parent drug, any known metabolites, and total radioactivity, metabolite profiling, metabolite identification, if suitable assays are available, safety and tolerability in healthy male subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Part 1: BI 1265162 - intravenous

Intravenous solution

DRUG

Part 2: BI 1265162 - oral

Oral solution

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-02-18
Primary Completion
2020-04-02
Completion
2020-04-02

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 NCT04267276 on ClinicalTrials.gov