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

Phase 1

Completed

• Conditions: Asthma; Rhinitis, Allergic, Perennial
• Interventions: Drug: BI 671800; Drug: placebo

• Registration Number: NCT01216384
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Primary Completion: 2010-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 73

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 671800 active	BI 671800	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.
Placebo	placebo	3 subjects will receive placebo in each of the 3 doses in the SRD part and 3 doses in the MRD part

Primary Outcome Measures

Name	Time	Method
Clinical laboratory tests (Clinical chemistry)	up to 4 days for SRD part and up to 15 days for MRD part
Clinical laboratory tests (Urinalysis)	up to 4 days for SRD part and up to 15 days for MRD part
Adverse events	up to 4 days for SRD part and up to 15 days for MRD part
Physical examination	up to 4 days for SRD part and up to 15 days for MRD part
Vital signs; Blood Pressure(BP)	up to 4 days for SRD part and up to 15 days for MRD part
Vital signs; Pulse rate(PR)	up to 4 days for SRD part and up to 15 days for MRD part
12-lead Electrocardiogram (ECG)	up to 4 days for SRD part and up to 15 days for MRD part
Clinical laboratory tests (Hematology)	up to 4 days for SRD part and up to 15 days for MRD part

Secondary Outcome Measures

Name	Time	Method
SRD Part, Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957	up to 4 days
SRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957	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	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	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	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	up to 4 days
SRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957	up to 4 days
SRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957	up to 4 days
SRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957	up to 4 days
SRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800	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	up to 4 days
MRD Part , Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957	day1 Visit2, day1 Visit3
MRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957	day1 Visit2, day1 Visit3
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
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
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
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
MRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957	day1 Visit2, day1 Visit3
MRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957	day1 Visit2, day1 Visit3
MRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957	day1 Visit2, day1 Visit3
MRD Part, Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose); only BI 671800	day1 Visit2, day1 Visit 3
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
MRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800	day1 Visit2, day1 Visit3
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	up to 12 days
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration); only BI 671800	up to 12 days
Linearity index (LI) of the analyte in plasma	up to 12 days
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
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	up to 12 days
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
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	up to 12 days
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
Accumulation ratios RA,AUC,13 based on AUC τ after the first dose and at steady state	up to 12 days
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
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
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
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
MRD Part,λz ,ss (terminal rate constant in plasma at steady state) BI 671800 and BI 600957	up to 12 days
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
Accumulation ratios RA,Cmax, 13 based on Cmax after the first dose and at steady state	up to 12 days

Trial Locations

Locations (1)

1268.15.8201 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of