Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 705564 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Boehringer Ingelheim0 sitesApril 5, 2019

ConditionsHealthy

InterventionsBI 705564 Placebo

DrugsBI 705564 Placebo

Overview

Phase: Phase 1
Intervention: BI 705564
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Primary Endpoint: Number [N (%)] of subjects with drug-related Adverse Events (AEs)
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 705564 in healthy male subjects following oral administration of single rising doses.

A secondary objective is the exploration of the PK including dose proportionality of BI 705564 after single dosing.

Registry

clinicaltrials.gov

Start Date

April 5, 2019

End Date

September 2, 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

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), Respiratory Rate (RR), body temperature), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
•Age of 20 to 50 years (incl.) at screening
•Body Mass Index (BMI) of 18.5 to 25.0 kg/m2 (incl.) at screening
•Signed and dated written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
•Male subject 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 the 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)
•Surgical sterilised (including hysterectomy) of the subject's female partner
•Exclusion criteria:

Exclusion Criteria

Not provided

Arms & Interventions

BI 705564

Intervention: BI 705564

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Number [N (%)] of subjects with drug-related Adverse Events (AEs)

Time Frame: Up to day 7

Secondary Outcomes

AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(Up to 72 hours)
Cmax (maximum measured concentration of the analyte in plasma)(Up to 72 hours)