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

November 18, 2013 updated by: Boehringer Ingelheim

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • 1268.15.8201 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: BI 671800 active
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.
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_COMPARATOR: Placebo
3 subjects will receive placebo in each of the 3 doses in the SRD part and 3 doses in the MRD part
Drug: placebo
Subjects will receive according to the dose group matching number of placebo tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Physical examination
Time Frame: up to 4 days for SRD part and up to 15 days for MRD part
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
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
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
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
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
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
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
up to 4 days for SRD part and up to 15 days for MRD part

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
SRD Part, Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957
Time Frame: up to 4 days
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
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
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
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
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
Time Frame: up to 4 days
up to 4 days
SRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957
Time Frame: up to 4 days
up to 4 days
SRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957
Time Frame: up to 4 days
up to 4 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
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
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
Time Frame: up to 4 days
up to 4 days
MRD Part , Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957
Time Frame: day1 Visit2, day1 Visit3
day1 Visit2, day1 Visit3
MRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957
Time Frame: day1 Visit2, day1 Visit3
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
Time Frame: day1 Visit2, day1 Visit3
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
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
Time Frame: day1 Visit2, day1 Visit3
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
Time Frame: day1 Visit2, day1 Visit3
day1 Visit2, day1 Visit3
MRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957
Time Frame: day1 Visit2, day1 Visit3
day1 Visit2, day1 Visit3
MRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957
Time Frame: day1 Visit2, day1 Visit3
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
day1 Visit2, day1 Visit3
MRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800
Time Frame: day1 Visit2, day1 Visit3
day1 Visit2, day1 Visit3
MRD Part, Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose); only BI 671800
Time Frame: day1 Visit2, day1 Visit 3
day1 Visit2, day1 Visit 3
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
Time Frame: up to 12 days
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
Time Frame: up to 12 days
up to 12 days
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
Time Frame: up to 12 days
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
Time Frame: up to 12 days
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
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
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
Time Frame: up to 12 days
up to 12 days
MRD Part,λz ,ss (terminal rate constant in plasma at steady state) BI 671800 and BI 600957
Time Frame: up to 12 days
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
Time Frame: up to 12 days
up to 12 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
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
Time Frame: up to 12 days
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
Time Frame: up to 12 days
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
up to 12 days
Accumulation ratios RA,AUC,13 based on AUC τ after the first dose and at steady state
Time Frame: up to 12 days
up to 12 days
Linearity index (LI) of the analyte in plasma
Time Frame: up to 12 days
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
Time Frame: up to day 9
up to day 9
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
up to day 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1268.15

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