This Study Tests BI 1467335 in Healthy Japanese and Caucasian Men. The Study Tests How Different Doses of BI 1467335 Are Taken up in the Body and How Well They Are Tolerated

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1467335; Drug: Placebo

• Registration Number: NCT03159455
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of the current study is to investigate the safety and tolerability of BI 1467335 in healthy Japanese male subjects following oral administration of multiple rising doses The Caucasian group will receive higher dose only.

A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 1467335 in healthy Japanese and Caucasian male subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-18
• Study Start: 2017-06-07
• Primary Completion: 2017-12-16
• Study Completion: 2017-12-16
• Status Verified: 2021-05
• Results First Submitted: 2021-05-11
• Results First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Results First Posted: 2021-06-04
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1467335	BI 1467335	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Drug-related Adverse Events	From first day of trial medication intake until end of trial, up to 48 days.	Percentage of subjects with investigator-defined drug-related Adverse Events (AEs) is reported.

Secondary Outcome Measures

Name	Time	Method
AUC0-24	At -0:05 hours (h):minutes (min) before dosing and at 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 23:55 h:min after first dose.	Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose (AUC0-24).
Cmax	At -0:05 hours (h):minutes (min) before dosing and at 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 23:55 h:min after first dose.	Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).
AUC0-24,28	At 647:55 hours (h):minutes (min) prior to dosing and at 648:15, 648:30, 648:45, 649:00, 649:30, 650:00, 651:00, 652:00, 654:00, 656:00, 658:00, 660:00 and 672:00 h:min after first drug administration.	Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of 28th dose (AUC0-24,28).
Cmax,28	At 647:55 hours (h):minutes (min) prior to dosing and at 648:15, 648:30, 648:45, 649:00, 649:30, 650:00, 651:00, 652:00, 654:00, 656:00, 658:00, 660:00 and 672:00 h:min after first drug administration.	Maximum measured concentration of BI 1467335 in plasma following administration of 28th dose (Cmax,28).

Trial Locations

Locations (2)

Souseikai Hakata Clinic; 🇯🇵 Fukuoka, Fukuoka, Japan

SOUSEIKAI Sumida Hospital; 🇯🇵 Tokyo, Sumida-ku, Japan