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This Study in Healthy Men Tests How Different Doses of BI 1265162 Are Taken up in the Body and How Well They Are Tolerated.

NCT03576144 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-02-23

Study results available
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Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 1265162 in healthy male subjects following inhalative administration of multiple rising doses.

Secondary objectives is the exploration of the pharmacokinetics (PK) including dose proportionality and time dependency of BI 1265162 after multiple dosing

Conditions

  • Healthy

Interventions

DRUG

BI 1265162

Multiple rising inhaled doses

DRUG

Placebo

Multiple rising inhaled doses

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-11
Primary Completion
2018-12-06
Completion
2018-12-06

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT03576144 on ClinicalTrials.gov