Clinical trial NCT01216384: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Rhinitis, Allergic, Perennial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-10-07
Enrollment: 73
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Physical examination
timeFrame: up to 4 days for SRD part and up to 15 days for MRD part
measure: Vital signs; Blood Pressure(BP)
timeFrame: up to 4 days for SRD part and up to 15 days for MRD part
measure: Vital signs; Pulse rate(PR)
timeFrame: up to 4 days for SRD part and up to 15 days for MRD part
measure: 12-lead Electrocardiogram (ECG)
timeFrame: up to 4 days for SRD part and up to 15 days for MRD part
measure: Clinical laboratory tests (Hematology)
timeFrame: up to 4 days for SRD part and up to 15 days for MRD part
measure: Clinical laboratory tests (Clinical chemistry)
timeFrame: up to 4 days for SRD part and up to 15 days for MRD part
measure: Clinical laboratory tests (Urinalysis)
timeFrame: up to 4 days for SRD part and up to 15 days for MRD part
measure: Adverse events
timeFrame: up to 4 days for SRD part and up to 15 days for MRD part
Secondary outcomes:
measure: SRD Part, Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957
timeFrame: up to 4 days
measure: SRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957
timeFrame: up to 4 days
measure: 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
timeFrame: up to 4 days
measure: 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
timeFrame: up to 4 days
measure: 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
timeFrame: up to 4 days
measure: SRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957
timeFrame: up to 4 days
measure: SRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957
timeFrame: up to 4 days
measure: SRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957
timeFrame: up to 4 days
measure: SRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957
timeFrame: up to 4 days
measure: SRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800
timeFrame: up to 4 days
measure: SRD Part, Vz/F (apparent volume of distribution during the terminal phase λ z following an oral dose); only BI 671800
timeFrame: up to 4 days
measure: MRD Part , Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957
timeFrame: day1 Visit2, day1 Visit3
measure: MRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957
timeFrame: day1 Visit2, day1 Visit3
measure: 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
timeFrame: day1 Visit2, day1 Visit3
measure: 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
timeFrame: day1 Visit2, day1 Visit3
measure: 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
timeFrame: day1 Visit2, day1 Visit3
measure: MRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957
timeFrame: day1 Visit2, day1 Visit3
measure: MRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957
timeFrame: day1 Visit2, day1 Visit3
measure: MRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957
timeFrame: day1 Visit2, day1 Visit3
measure: MRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957
timeFrame: day1 Visit2, day1 Visit3
measure: MRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800
timeFrame: day1 Visit2, day1 Visit3
measure: MRD Part, Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose); only BI 671800
timeFrame: day1 Visit2, day1 Visit 3
measure: 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
timeFrame: up to 12 days
measure: MRD Part, tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957
timeFrame: up to 12 days
measure: 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
timeFrame: up to 12 days
measure: MRD Part,tmin,ss (time from last dosing to minimum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957
timeFrame: up to 12 days
measure: MRD Part,Cpre,ss (predose concentration of the analyte in plasma immediately before administration of dose at steady state) BI 671800 and BI 600957
timeFrame: up to 12 days
measure: 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
timeFrame: up to 12 days
measure: 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
timeFrame: up to 12 days
measure: MRD Part,λz ,ss (terminal rate constant in plasma at steady state) BI 671800 and BI 600957
timeFrame: up to 12 days
measure: MRD Part,t1/2,ss (terminal half-life of the analyte in plasma at steady state) BI 671800 and BI 600957
timeFrame: up to 12 days
measure: MRTpo,ss (mean residence time of the analyte in the body at steady state after xx administration) BI 671800 and BI 600957
timeFrame: up to 12 days
measure: CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration); only BI 671800
timeFrame: up to 12 days
measure: Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration); only BI 671800
timeFrame: up to 12 days
measure: Accumulation ratios RA,Cmax, 13 based on Cmax after the first dose and at steady state
timeFrame: up to 12 days
measure: Accumulation ratios RA,AUC,13 based on AUC τ after the first dose and at steady state
timeFrame: up to 12 days
measure: Linearity index (LI) of the analyte in plasma
timeFrame: up to 12 days
measure: 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
timeFrame: up to day 9
measure: 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
timeFrame: up to day 9
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 1268.15.8201 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: