Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of BI 1744 CL Plus BI 54903 XX Via Respimat® B Versus the Free Combination of BI 1744 CL Via Respimat® A and BI 54903 XX Via Respimat® B in Healthy Male and Female Volunteers

NCT02220660 | Completed Phase 1

• 1 other identifier: 1256.2
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study was to compare the systemic exposure of BI 1744 BS and CD 1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following inhalation of the fixed dose combination (FDC) BI 1744 CL plus BI 54903 XX (as ethanolic solution for inhalation, EIS) with the systemic exposure following inhalation of the free dose combination of BI 1744 CL (as aqueous solution for inhalation, AIS) and BI 54903 XX (EIS), respectively, when administered once-daily via Respimat® Inhaler (Respimat® A for AIS and Respimat® B for EIS) for 14 days in healthy volunteers. Secondary objectives were: to compare exposure to BI 1744 BS and CD 1857 XX after a single dose of the BI 1744 CL/BI 54903 XX FDC and the free dose combination, respectively; to compare exposure to BI 54903 XX after a single dose and at steady state after multiple doses of the BI 1744 CL/BI 54903 XX fixed dose combination and the free dose combination, respectively; to compare the safety and tolerability of BI 1744 CL and BI 54903 XX when administered as BI 1744 CL/BI 54903 XX fixed dose combination and as the free dose combination, respectively.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-t,ss (area under the concentration time curve of the analyte in plasma from 0 to time t at steady state)

  up to 24 hours after drug administration

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 24 hours after drug administration

Secondary Outcomes (14)

• AUC0-t,ss (area under the concentration time curve of the analyte in plasma from 0 to time t at steady state)

  up to 24 hours after drug administration

• Cpre (pre-dose concentration of the analyte in plasma)

  immediately before drug administration

• AUCt1-t2 (area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)

  up to 24 hours after drug administration

• AUC0-t (area under the concentration time curve of the analyte in plasma from 0 to time t)

  up to 24 hours after drug administration

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 24 hours after drug administration

Study Arms (2)

Free dose combination

ACTIVE COMPARATOR

Drug: BI 1744 CL; Drug: BI 54903 XX

Fixed dose combination

EXPERIMENTAL

Drug: BI 1744 CL + BI 54903 XX FDC; Drug: Placebo

Interventions

BI 1744 CL DRUG

Free dose combination

BI 54903 XX DRUG

Free dose combination

BI 1744 CL + BI 54903 XX FDC DRUG

Fixed dose combination

Placebo DRUG

Fixed dose combination

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
• Age \>= 21 and \<= 50 years
• BMI \>= 18.5 and \<= 29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• alcohol abuse (more than 40 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

olodaterol

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 20, 2014
• Study Start: March 1, 2009
• Primary Completion: June 1, 2009
• Last Updated: August 20, 2014

Record last verified: 2014-08