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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651598
• Other study ID #: 1313.2
• Secondary ID: 2012-001615-23
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2012
• Last updated: October 31, 2013
• Start date: July 2012
• Est. completion date: January 2013

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Healthy

Intervention

Drug:
• Placebo to BI 144807
multiple dose (bid)
• BI 144807
multiple dose (bid, low to high dose)

Locations

Country	Name	City	State
United Kingdom	1313.2.44001 Boehringer Ingelheim Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number (% patients) of drug-related adverse events		up to 28 days	No
Secondary	Maximum measured concentration of the analyte in plasma after first dose (Cmax)		up to 24 hours after first dose	No
Secondary	Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss)		up to 72 hours after last dose	No
Secondary	Time from first dosing to maximum measured concentration (Tmax)		up to 24 hours after first dose	No
Secondary	Time from last dosing to maximum measured concentration (Tmax,ss)		up to 72 hours after last dose	No
Secondary	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	No
Secondary	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)		up to 72 hours after last dose	No
Secondary	Terminal half-life of the analyte in plasma after the first dose (t1/2)		up to 24 hours after first dose	No
Secondary	Terminal half-life of the analyte in plasma at steady state (t1/2,ss)		up to 72 hours after last dose	No
Secondary	RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose)		up to 72 hours after last dose	No
Secondary	RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose)		up to 72 hours after last dose	No