NCT01216384

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P75+ for phase_1 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

2 months

First QC Date

October 1, 2010

Last Update Submit

November 18, 2013

Conditions

AsthmaRhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

Secondary Outcomes (39)

  • 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

  • +34 more secondary outcomes

Study Arms (2)

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.

Drug: BI 671800

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

Drug: placebo

Interventions

BI 671800DRUG

In the SRD part subjects will receive a single dose and in the MRD part subjects will receive a total of 14 doses.

BI 671800 active
placeboDRUG

Subjects will receive according to the dose group matching number of placebo tablets

Placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Chinese ethnicity for single rising dose (SRD) part, Japanese Ethnicity for multiple rising dose (MRD) part.
  • Age \>= 20 and age =\< 50
  • Body Mass Index (BMI) \>=18.5 and BMI =\< 25 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

You may not qualify if:

  • 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
  • Any evidence of a clinically relevant concomitant disease
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1268.15.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

MeSH Terms

Conditions

AsthmaRhinitis, Allergic, Perennial

Interventions

BI 671800

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitis, AllergicRhinitisNose DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 7, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2010

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

KR(1)