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A Study in Healthy Japanese and Chinese Men to Test How Well Different Doses of BI 706321 Are Tolerated

NCT05183360 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-23

Study results available
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Summary

Part I: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Japanese male subjects following oral administration of multiple rising doses.

Part II: The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 706321 in healthy Chinese male subjects following oral administration of single dose.

Conditions

  • Healthy

Interventions

DRUG

BI 706321

BI 706321, tablet, oral use

DRUG

Placebo

Placebo, tablet, oral use

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2022-08-12
Completion
2024-08-08

Countries

  • Japan

Study Locations

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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 NCT05183360 on ClinicalTrials.gov