Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BEA 2180 BR in Healthy Male Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BEA 2180 BR; Drug: Spiriva; Drug: Placebo; Drug: Methacholine Chloride; Device: Respimat® A 4

Study type: Interventional

Funder types: Industry

Identifiers

NCT02263976

1205.9001 (Other Identifier)

1205.1

Details and patient eligibility

About

Main study: To investigate safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of BEA 2180 BR Sub-study; To investigate whether treatment with 36 μg tiotropium bromide is able to protect of methacholine-induced bronchoconstriction compared to baseline (methacholine challenge at screening).

Enrollment: 101 patients

Sex: Male

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory test
• No finding deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥ 30 and Age ≤ 55 years
• Body Mass Index (BMI) ≥ 18.5 and BMI < 30 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion criteria

• 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 allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator (or his deputy)
• 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
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)
• Any laboratory value outside the reference range of clinical relevance

Exclusion criteria specific for this study:

• Bronchial hyperreactivity as demonstrated by a 45% change of SGaw at or below a cumulative methacholine concentration of 10 mg/mL = 1%
• Asthma or bronchial hyperreactivity
• Allergic rhinitis (hay fever)
• Glaucoma
• Urinary tract obstruction
• Epilepsy
• History of cardiovascular disease
• History of peptic ulcer disease
• History of thyroid disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 3 patient groups, including a placebo group

BEA 2180 BR

Experimental group

Description:

single rising doses

Treatment:

Drug: Methacholine Chloride

Device: Respimat® A 4

Drug: BEA 2180 BR

Placebo

Placebo Comparator group

Treatment:

Drug: Methacholine Chloride

Device: Respimat® A 4

Drug: Placebo

Sub-Study

Experimental group

Treatment:

Drug: Methacholine Chloride

Drug: Spiriva