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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216384
• Other study ID #: 1268.15
• Status: Completed
• Phase: Phase 1
• First received: October 1, 2010
• Last updated: November 18, 2013
• Start date: October 2010

Study information

• Verified date: November 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• BI 671800
In the SRD part subjects will receive a single dose and in the MRD part subjects will receive a total of 14 doses.
• placebo
Subjects will receive according to the dose group matching number of placebo tablets

Locations

Country	Name	City	State
Korea, Republic of	1268.15.8201 Boehringer Ingelheim Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical examination		up to 4 days for SRD part and up to 15 days for MRD part	No
Primary	Vital signs; Blood Pressure(BP)		up to 4 days for SRD part and up to 15 days for MRD part	No
Primary	Vital signs; Pulse rate(PR)		up to 4 days for SRD part and up to 15 days for MRD part	No
Primary	12-lead Electrocardiogram (ECG)		up to 4 days for SRD part and up to 15 days for MRD part	No
Primary	Clinical laboratory tests (Hematology)		up to 4 days for SRD part and up to 15 days for MRD part	No
Primary	Clinical laboratory tests (Clinical chemistry)		up to 4 days for SRD part and up to 15 days for MRD part	No
Primary	Clinical laboratory tests (Urinalysis)		up to 4 days for SRD part and up to 15 days for MRD part	No
Primary	Adverse events		up to 4 days for SRD part and up to 15 days for MRD part	No
Secondary	SRD Part, Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957		up to 4 days	No
Secondary	SRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957		up to 4 days	No
Secondary	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		up to 4 days	No
Secondary	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		up to 4 days	No
Secondary	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		up to 4 days	No
Secondary	SRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957		up to 4 days	No
Secondary	SRD Part, ?z (terminal rate constant in plasma) ), BI 671800 and BI 600957		up to 4 days	No
Secondary	SRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957		up to 4 days	No
Secondary	SRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957		up to 4 days	No
Secondary	SRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800		up to 4 days	No
Secondary	SRD Part, Vz/F (apparent volume of distribution during the terminal phase ? z following an oral dose); only BI 671800		up to 4 days	No
Secondary	MRD Part , Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957		day1 Visit2, day1 Visit3	No
Secondary	MRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957		day1 Visit2, day1 Visit3	No
Secondary	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		day1 Visit2, day1 Visit3	No
Secondary	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		day1 Visit2, day1 Visit3	No
Secondary	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		day1 Visit2, day1 Visit3	No
Secondary	MRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957		day1 Visit2, day1 Visit3	No
Secondary	MRD Part, ?z (terminal rate constant in plasma) ), BI 671800 and BI 600957		day1 Visit2, day1 Visit3	No
Secondary	MRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957		day1 Visit2, day1 Visit3	No
Secondary	MRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957		day1 Visit2, day1 Visit3	No
Secondary	MRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800		day1 Visit2, day1 Visit3	No
Secondary	MRD Part, Vz/F (apparent volume of distribution during the terminal phase ?z following an oral dose); only BI 671800		day1 Visit2, day1 Visit 3	No
Secondary	MRD Part, Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t, BI 671800 and BI 600957		up to 12 days	No
Secondary	MRD Part, tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957		up to 12 days	No
Secondary	MRD Part, Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval t) BI 671800 and BI 600957		up to 12 days	No
Secondary	MRD Part,tmin,ss (time from last dosing to minimum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957		up to 12 days	No
Secondary	MRD Part,Cpre,ss (predose concentration of the analyte in plasma immediately before administration of dose at steady state) BI 671800 and BI 600957		up to 12 days	No
Secondary	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		up to 12 days	No
Secondary	MRD Part,AUC t,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) BI 671800 and BI 600957		up to 12 days	No
Secondary	MRD Part,?z ,ss (terminal rate constant in plasma at steady state) BI 671800 and BI 600957		up to 12 days	No
Secondary	MRD Part,t1/2,ss (terminal half-life of the analyte in plasma at steady state) BI 671800 and BI 600957		up to 12 days	No
Secondary	MRTpo,ss (mean residence time of the analyte in the body at steady state after xx administration) BI 671800 and BI 600957		up to 12 days	No
Secondary	CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration); only BI 671800		up to 12 days	No
Secondary	Vz/F,ss (apparent volume of distribution during the terminal phase ?z at steady state following extravascular administration); only BI 671800		up to 12 days	No
Secondary	Accumulation ratios RA,Cmax, 13 based on Cmax after the first dose and at steady state		up to 12 days	No
Secondary	Accumulation ratios RA,AUC,13 based on AUC t after the first dose and at steady state		up to 12 days	No
Secondary	Linearity index (LI) of the analyte in plasma		up to 12 days	No
Secondary	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		up to day 9	No
Secondary	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		up to day 9	No