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A Study in Healthy Japanese Men to Test How Different Doses of BI 690517 Are Taken Up in the Body and How Well They Are Tolerated

NCT03608072 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-11-25

No results posted yet for this study

Summary

The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy Japanese male subjects following oral administration of multiple rising doses over 14 days.

Secondary objective is the exploration of the pharmacokinetic(s) (PK) and pharmacodynamic(s) (PD) of BI 690517 in healthy Japanese male subjects after multiple dosing.

Conditions

  • Healthy

Interventions

DRUG

BI 690517

3 sequential dose groups

DRUG

Placebo

3 sequential dose groups

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-06
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Japan

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 NCT03608072 on ClinicalTrials.gov