Study to Investigate Safety and Tolerability of BI 1744 CL in Free Dose Combination With Tiotropium Bromide Both Administered by Respimat® in Healthy Male Volunteers

NCT02259946 | Completed Phase 1

• 1 other identifier: 1237.1
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate safety and tolerability of single, inhaled doses (2.5 μg, 5 μg, 10 μg, 20 μg and 40 μg) of BI 1744 CL in free dose combination with tiotropium bromide 5 μg (for doses up to and including 20 μg BI 1744 CL) and 10 μg (for doses of 20 μg and 40 μg BI 1744 CL), both administered by Respimat® in healthy male volunteers. Also, to investigate the pharmacokinetics of BI 1744 BS and tiotropium bromide in such combinations, to explore their dose proportionality, and to explore the pharmacodynamic effects of the treatments on selected metabolic and respiratory parameters

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

• Number of participants with abnormal findings in physical examination

  up to 12 days after drug administration

• Number of participants with abnormal changes in laboratory parameters

  up to 12 days after drug administration

• Number of participants with clinically significant changes in vital signs

  blood pressure (BP), pulse rate (PR), respiratory rate (RR)

  up to 12 days after drug administration

• Number of participants with adverse events

  up to 12 days after drug administration

• Number of participants with clinically significant changes in 12-lead ECG

  cardiac axis, heart rate, PQ interval, QRS interval, uncorrected QT interval, HR-corrected QT-interval according to Bazett and Fridericia

  up to 12 days after drug administration

• Number of abnormal findings on oropharyngeal inspection

  up to 24 hours after drug administration

• Number of abnormal findings on pulmonary auscultation

  up to 24 hours after drug administration

• Assessment of tolerability by investigator on a 4-point scale

  12 days after drug administration

• Change in Airway resistance (Raw)

  measured by whole-body plethysmography

  up to 24 hours after drug administration

• Change in specific conductance (sGaw)

  measured by whole-body plethysmography

  up to 24 hours after drug administration

• Change in Cyclic aminomonophosphate (cAMP)

  up to 6 hours after drug administration

• Change in potassium

  up to 6 hours after drug administration

Secondary Outcomes (13)

• Cmax (maximum measured concentration of BI 1744 BS and tiotropium in plasma)

  up to 96 hours after drug administration

• tmax (time from dosing to maximum measured concentration)

  up to 96 hours after drug administration

• AUC0-∞ (area under the concentration-time curve of BI 1744 BS and tiotropium in plasma over the time interval from 0 extrapolated to infinity)

  up to 96 hours after drug administration

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

  up to 96 hours after drug administration

• %AUCtz-∞ (percentage of the extrapolated part of the total AUC0-∞)

  up to 96 hours after drug administration

Study Arms (2)

BI 1744 CL - single rising dose + Tiotropium

EXPERIMENTAL

Single rising dose of BI 1744 CL (conjointly with Tiotropium bromide)

Drug: BI 1744 CL; Drug: Tiotropium bromide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1744 CL DRUG

BI 1744 CL - single rising dose + Tiotropium

Placebo DRUG

Placebo

Tiotropium bromide DRUG

BI 1744 CL - single rising dose + Tiotropium

Eligibility Criteria

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

You may qualify if:

• Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG measurement, and clinical laboratory tests. Absence of any clinically relevant abnormality. Absence of any clinically relevant concomitant disease
• Age ≥21 and ≤50 years
• BMI ≥18.5 and \<30 kg/m2 (Body Mass Index)
• 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 measurements) deviating from normal and of clinical relevance
• Evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• 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 the drug or its excipients) as judged clinically relevant by the investigator
• Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomization
• 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 enrolment in the study or during the study
• Participation in another trial with an investigational drug within 2 months prior to randomization
• Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days as judged by the investigator
• Alcohol abuse (regularly more than 40 g alcohol per day for men)
• Drug abuse
• Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

olodaterol; Tiotropium Bromide

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

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: October 7, 2014
• First Posted: October 9, 2014
• Study Start: April 1, 2006
• Primary Completion: July 1, 2006
• Last Updated: October 9, 2014

Record last verified: 2014-10