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Clinical Trials/NCT01216384
NCT01216384CompletedPhase 1

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

Boehringer Ingelheim1 site in 1 country73 target enrollmentStarted: October 2010Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
73
Locations
1
Primary Endpoint
Adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

BI 671800 active

Experimental

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.

Intervention: BI 671800 (Drug)

Placebo

Placebo Comparator

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

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

Adverse events

Time Frame: up to 4 days for SRD part and up to 15 days for MRD part

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

12-lead Electrocardiogram (ECG)

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

Clinical laboratory tests (Clinical chemistry)

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

Secondary Outcomes

  • 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,t1/2,ss (terminal half-life of the analyte in plasma at steady state) BI 671800 and BI 600957(up to 12 days)
  • 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)
  • Accumulation ratios RA,Cmax, 13 based on Cmax after the first dose and at steady state(up to 12 days)
  • 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)

Investigators

Sponsor Class
Industry

Study Sites (1)

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