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A Study in Healthy Men to Test How Different Doses of BI 1584862 Are Tolerated and How BI 1584862 is Taken up in the Body With or Without Food

NCT05520827 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2023-03-09

No results posted yet for this study

Summary

Single Rising Dose (SRD) part:

The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 1584862 in healthy male subjects following oral administration of single rising doses.

Food Effect (FE) part:

The main objective of the FE part is to assess the influence of food on the relative bioavailability of the BI 1584862 tablet.

Conditions

  • Healthy

Interventions

DRUG

BI 1584862

BI 1584862

DRUG

Placebo

Placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-09-29
Primary Completion
2023-03-06
Completion
2023-03-06

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 NCT05520827 on ClinicalTrials.gov