Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers

Boehringer Ingelheim73 enrolled

Overview

The primary objective of the current study is to investigate the safety and tolerability of BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and healthy Japanese male volunteers following single oral administration and multiple administrations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma Rhinitis, Allergic, Perennial

Interventions

BI 671800DRUG

In the SRD part subjects will receive a single dose and in the MRD part subjects will receive a total of 14 doses.

placeboDRUG

Subjects will receive according to the dose group matching number of placebo tablets

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1. Healthy 2. Chinese ethnicity for single rising dose (SRD) part, Japanese Ethnicity for multiple rising dose (MRD) part. 3. Age \>= 20 and age =\< 50 4. Body Mass Index (BMI) \>=18.5 and BMI =\< 25 kg/m2 5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation Exclusion criteria: 1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement 2. Any evidence of a clinically relevant concomitant disease 3. Intake of drugs with long half life (\>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration

Locations (1)

1268.15.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

Physical examination

Time frame: up to 4 days for SRD part and up to 15 days for MRD part

Vital signs; Blood Pressure(BP)

Time frame: up to 4 days for SRD part and up to 15 days for MRD part

Vital signs; Pulse rate(PR)

Time frame: up to 4 days for SRD part and up to 15 days for MRD part

12-lead Electrocardiogram (ECG)

Time frame: up to 4 days for SRD part and up to 15 days for MRD part

Clinical laboratory tests (Hematology)

Time frame: up to 4 days for SRD part and up to 15 days for MRD part

Clinical laboratory tests (Clinical chemistry)

Time frame: up to 4 days for SRD part and up to 15 days for MRD part

Clinical laboratory tests (Urinalysis)

Time frame: up to 4 days for SRD part and up to 15 days for MRD part

Adverse events

Time frame: up to 4 days for SRD part and up to 15 days for MRD part

Secondary Outcomes

SRD Part, Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957

Time frame: up to 4 days

SRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957

Time frame: up to 4 days

SRD Part, AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time point t1 to time point t2), BI 671800 and BI 600957

Data from ClinicalTrials.gov

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Time frame: up to 4 days

SRD Part, AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz) BI 671800 and BI 600957

Time frame: up to 4 days

SRD Part, AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), BI 671800 and BI 600957

Time frame: up to 4 days

SRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957

Time frame: up to 4 days

SRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957

Time frame: up to 4 days

SRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957

Time frame: up to 4 days

SRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957

Time frame: up to 4 days

SRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800

Time frame: up to 4 days

SRD Part, Vz/F (apparent volume of distribution during the terminal phase λ z following an oral dose); only BI 671800

Time frame: up to 4 days

MRD Part , Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957