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

Primary Purpose

Asthma, Rhinitis, Allergic, Perennial

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

BI 671800

placebo

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion criteria:

Healthy
Chinese ethnicity for single rising dose (SRD) part, Japanese Ethnicity for multiple rising dose (MRD) part.
Age >= 20 and age =< 50
Body Mass Index (BMI) >=18.5 and BMI =< 25 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion criteria:

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
Any evidence of a clinically relevant concomitant disease
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

Sites / Locations

1268.15.8201 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BI 671800 active

Placebo

Arm Description

SRD part: 3 dose groups each consisting of 12 subjects (9 active, 3 placebo), subjects receive single dose. MRD part: 3 dose groups each consisting of 12 subjects (9 active, 3 placebo), subjects receive single dose followed by multiple doses with a PK sampling interval in between.

3 subjects will receive placebo in each of the 3 doses in the SRD part and 3 doses in the MRD part

Outcomes

Primary Outcome Measures

Physical examination

Vital signs; Blood Pressure(BP)

Vital signs; Pulse rate(PR)

12-lead Electrocardiogram (ECG)

Clinical laboratory tests (Hematology)

Clinical laboratory tests (Clinical chemistry)

Clinical laboratory tests (Urinalysis)

Adverse events

Secondary Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

MRD 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

MRD 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

MRD 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

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

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

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

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

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

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

MRD Part, Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, BI 671800 and BI 600957

MRD Part, tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957

MRD Part, Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) BI 671800 and BI 600957

MRD Part,tmin,ss (time from last dosing to minimum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957

MRD Part,Cpre,ss (predose concentration of the analyte in plasma immediately before administration of dose at steady state) BI 671800 and BI 600957

MRD Part,AUCt1-t2,ss (area under the concentration-time curve of the analyte in plasma at steady state over the time interval t1 to t2) BI 671800 and BI 600957

MRD Part,AUC τ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) BI 671800 and BI 600957

MRD Part,λz ,ss (terminal rate constant in plasma at steady state) BI 671800 and BI 600957

MRD Part,t1/2,ss (terminal half-life of the analyte in plasma at steady state) BI 671800 and BI 600957

MRTpo,ss (mean residence time of the analyte in the body at steady state after xx administration) BI 671800 and BI 600957

CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration); only BI 671800

Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration); only BI 671800

Accumulation ratios RA,Cmax, 13 based on Cmax after the first dose and at steady state

Accumulation ratios RA,AUC,13 based on AUC τ after the first dose and at steady state

Linearity index (LI) of the analyte in plasma

AUEC0-24,N absolute inhibition of eosinophil shape change: area under the absolute inhibition of shape change-time curve after the Nth dose of BI 671800 HEA

AUEC0-24,N percent inhibition of eosinophil shape change: area under the percent inhibition of shape change - time curve after the Nth dose of BI 671800

Full Information

NCT ID

NCT01216384

First Posted

October 1, 2010

Last Updated

November 18, 2013

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01216384

Brief Title

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

Official Title

A Randomised, Double-blind (Within Dose Groups), Parallel Group, Placebocontrolled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Rising Doses (50 mg, 200 mg, 400 mg) of BI 671800 HEA in Chinese Healthy Male Volunteers and Multiple Rising Doses (50 mg b.i.d., 200 mg b.i.d., 400 mg b.i.d.) of BI 671800 HEA in Japanese Healthy Male Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Rhinitis, Allergic, Perennial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BI 671800 active

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

3 subjects will receive placebo in each of the 3 doses in the SRD part and 3 doses in the MRD part

Intervention Type

Drug

Intervention Name(s)

BI 671800

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Physical examination

Time Frame