Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01651598
First received: July 23, 2012
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Healthy
Asthma
Drug: Placebo to BI 144807
Drug: BI 144807
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Multiple Rising Doses of BI 144807 Powder for Oral Drinking Solution Over a Period of 14 Days in Otherwise Healthy Controlled Asthmatic Subjects in a Randomised, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number (% patients) of drug-related adverse events [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum measured concentration of the analyte in plasma after first dose (Cmax) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss) [ Time Frame: up to 72 hours after last dose ] [ Designated as safety issue: No ]
  • Time from first dosing to maximum measured concentration (Tmax) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • Time from last dosing to maximum measured concentration (Tmax,ss) [ Time Frame: up to 72 hours after last dose ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss) [ Time Frame: up to 72 hours after last dose ] [ Designated as safety issue: No ]
  • Terminal half-life of the analyte in plasma after the first dose (t1/2) [ Time Frame: up to 24 hours after first dose ] [ Designated as safety issue: No ]
  • Terminal half-life of the analyte in plasma at steady state (t1/2,ss) [ Time Frame: up to 72 hours after last dose ] [ Designated as safety issue: No ]
  • RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose) [ Time Frame: up to 72 hours after last dose ] [ Designated as safety issue: No ]
  • RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of AUC at steady state and after single dose) [ Time Frame: up to 72 hours after last dose ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 144807
Subjects receive multiple BID doses of BI 144807 solution
Drug: BI 144807
multiple dose (bid, low to high dose)
Placebo Comparator: Placebo
Subjects receive multiple BID doses of Placebo solution
Drug: Placebo to BI 144807
multiple dose (bid)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

1. Apart from mild asthma any relevant deviation from healthy conditions

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651598

Locations
United Kingdom
1313.2.44001 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01651598     History of Changes
Other Study ID Numbers: 1313.2, 2012-001615-23
Study First Received: July 23, 2012
Last Updated: October 31, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014