NCT01651598

Brief Summary

In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple dose administration of BI 144807 will be investigated in otherwise healthy, controlled asthmatic patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2012

Typical duration for phase_1 healthy

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

Study Start

First participant enrolled

July 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

6 months

First QC Date

July 23, 2012

Last Update Submit

October 31, 2013

Conditions

HealthyAsthma

Outcome Measures

Primary Outcomes (1)

  • Number (% patients) of drug-related adverse events

    up to 28 days

Secondary Outcomes (10)

  • Maximum measured concentration of the analyte in plasma after first dose (Cmax)

    up to 24 hours after first dose

  • Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss)

    up to 72 hours after last dose

  • Time from first dosing to maximum measured concentration (Tmax)

    up to 24 hours after first dose

  • Time from last dosing to maximum measured concentration (Tmax,ss)

    up to 72 hours after last dose

  • Area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2 after administration of the first dose (AUCt1-t2)

    up to 24 hours after first dose

  • +5 more secondary outcomes

Study Arms (2)

BI 144807

EXPERIMENTAL

Subjects receive multiple BID doses of BI 144807 solution

Drug: BI 144807

Placebo

PLACEBO COMPARATOR

Subjects receive multiple BID doses of Placebo solution

Drug: Placebo to BI 144807

Interventions

Placebo to BI 144807DRUG

multiple dose (bid)

Placebo
BI 144807DRUG

multiple dose (bid, low to high dose)

BI 144807

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. mild asthmatic, otherwise healthy subjects (male and female of non-childbearing potential)

You may not qualify if:

  • \. Apart from mild asthma any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1313.2.44001 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System 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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 27, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

GB(1)