Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide in Healthy Male Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and Tiotropium Bromide when given as fixed dose combination

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Bromides; Olodaterol; Pharmaceutical Solutions; Tiotropium Bromide

Criteria

Inclusion Criteria:

• Healthy male based upon a complete medical history, including physical examination, regarding vital signs (BP, PR), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease

• Age ≥21 and ≤45 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 randomisation

• Participation in another trial with an investigational drug within 2 months prior to randomisation

• 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 (more than 40 g alcohol a day)

• 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 randomisation 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

The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:

• Asthma or history of pulmonary hyperreactivity

• Hyperthyrosis

• Allergic rhinitis in need of treatment

• Clinically relevant cardiac arrhythmia

• Paroxysmal tachycardia (>100 beats per minute)

The following exclusion criteria are specific for this study due to the known class side effect profile of Tiotropium:

• Hypersensitivity to tiotropium and/or related drugs of these classes

• History of narrow-angle glaucoma

• History of prostatic hyperplasia

• History of bladder-neck obstruction