Clinical Trials/NCT03608072

NCT03608072

Completed

Phase 1

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 690517 in Healthy Japanese Male Subjects (double-blind, Randomised, Placebo-controlled Within Dose Groups)

Boehringer Ingelheim1 site in 1 country36 target enrollmentAugust 6, 2018

ConditionsHealthy

InterventionsBI 690517 Placebo

DrugsBI 690517 Placebo

Overview

Phase: Phase 1
Intervention: BI 690517
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Enrollment: 36
Locations: 1
Primary Endpoint: Number [N (%)] of subjects with drug-related adverse events (AEs)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 6, 2018

End Date

January 31, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
•Japanese ethnicity, according to the following criteria:
•- born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese
•Age of 20 to 50 years (incl.)
•Body mass index (BMI) of 18.5 to 25.0 kg/m2 (incl.)
•Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
•Male subjects who agree to minimize the risk of female partners becoming pregnant by fulfilling any of the following criteria starting from at least 30 days before the first administration of trial medication and until 90 days after trial completion:
•Use of adequate contraception, e.g. any of the following methods plus condom:
•-- combined oral contraceptives, intrauterine device
•Vasectomised (vasectomy at least 1 year prior to enrolment)

Exclusion Criteria

Not provided

Arms & Interventions

Dose group 1

Intervention: BI 690517

Dose group 1

Intervention: Placebo

Dose group 2

Intervention: BI 690517

Dose group 2

Intervention: Placebo

Dose group 3

Intervention: BI 690517

Dose group 3

Intervention: Placebo

Outcomes

Primary Outcomes

Number [N (%)] of subjects with drug-related adverse events (AEs)

Time Frame: Up to day 19

Secondary Outcomes

AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose [AUCτ,1 will be AUC0-24])(up to 24 hours)
Cmax (maximum measured concentration of the analyte in plasma)(Up to 24 hours)
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)(After 312 hours and up to 360 hours)
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)(After 312 hours and up to 360 hours)