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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01216384
• Date of registration: 01/10/2010
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers
• Scientific 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
• Date of first enrolment: October 2010
• Target sample size: 73
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01216384
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Korea, Republic of

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Asthma

Rhinitis, Allergic, Perennial

Intervention(s)

Drug: placebo

Drug: BI 671800

Primary Outcome(s)

Clinical laboratory tests (Urinalysis) [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]

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]

Adverse events [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]

12-lead Electrocardiogram (ECG) [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]

Secondary Outcome(s)

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 [Time Frame: up to day 9]

Linearity index (LI) of the analyte in plasma [Time Frame: up to 12 days]

MRD Part,?z ,ss (terminal rate constant in plasma at steady state) BI 671800 and BI 600957 [Time Frame: 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 [Time Frame: up to 12 days]

MRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957 [Time Frame: day1 Visit2, day1 Visit3]

MRD Part, ?z (terminal rate constant in plasma) ), BI 671800 and BI 600957 [Time Frame: day1 Visit2, day1 Visit3]

MRD Part,tmin,ss (time from last dosing to minimum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957 [Time Frame: 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 [Time Frame: up to day 9]

CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration); only BI 671800 [Time Frame: up to 12 days]

Accumulation ratios RA,AUC,13 based on AUC t after the first dose and at steady state [Time Frame: up to 12 days]

Accumulation ratios RA,Cmax, 13 based on Cmax after the first dose and at steady state [Time Frame: up to 12 days]

MRD Part , Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957 [Time Frame: day1 Visit2, day1 Visit3]

MRD Part, tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957 [Time Frame: up to 12 days]

MRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957 [Time Frame: day1 Visit2, day1 Visit3]

MRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957 [Time Frame: day1 Visit2, day1 Visit3]

SRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957 [Time Frame: up to 4 days]

MRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957 [Time Frame: 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 [Time Frame: day1 Visit2, day1 Visit3]

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 [Time Frame: up to 12 days]

SRD Part, ?z (terminal rate constant in plasma) ), BI 671800 and BI 600957 [Time Frame: up to 4 days]

SRD Part, Vz/F (apparent volume of distribution during the terminal phase ? z following an oral dose); only BI 671800 [Time Frame: up to 4 days]

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 [Time Frame: day1 Visit2, day1 Visit3]

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 [Time Frame: 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 [Time Frame: up to 12 days]

MRD Part, Vz/F (apparent volume of distribution during the terminal phase ?z following an oral dose); only BI 671800 [Time Frame: day1 Visit2, day1 Visit 3]

MRD Part,t1/2,ss (terminal half-life of the analyte in plasma at steady state) BI 671800 and BI 600957 [Time Frame: up to 12 days]

MRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800 [Time Frame: day1 Visit2, day1 Visit3]

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, 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]

MRTpo,ss (mean residence time of the analyte in the body at steady state after xx administration) BI 671800 and BI 600957 [Time Frame: up to 12 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, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957 [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, 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 [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, Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957 [Time Frame: up to 4 days]

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 [Time Frame: day1 Visit2, day1 Visit3]

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 [Time Frame: up to 12 days]

Vz/F,ss (apparent volume of distribution during the terminal phase ?z at steady state following extravascular administration); only BI 671800 [Time Frame: up to 12 days]

Secondary ID(s)

1268.15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors