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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Tiotropium bromide

Drug: BI 1744 CL

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02259946

1237.1

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

Male

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)
Excessive physical activities within 1 week prior to randomization or during the trial
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of the study centre

Additionally, following exclusion criteria that are of particular relevance with regard to the known properties of BI 1744 CL as a ß-adrenoceptor agonist must be adhered to:
Asthma or history of pulmonary hyperreactivity
Hyperthyrosis
Allergic rhinitis in need of treatment
Clinically relevant cardiac arrhythmia
Paroxysmal tachycardia

Furthermore, the following exclusion criteria that are of particular relevance with regard to the known properties of tiotropium as an antimuscarinic anticholinergic agent must be adhered to:
Hypersensitivity to tiotropium and/or related drugs of these classes
History of narrow-angle glaucoma
History of prostatic hyperplasia
History of bladder-neck obstruction