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

NCT ID: NCT02263976

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31

Brief Summary

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BEA 2180 BR

single rising doses

Group Type: EXPERIMENTAL

BEA 2180 BR

Intervention Type: DRUG

Respimat® A 4

Intervention Type: DEVICE

Methacholine Chloride

Intervention Type: DRUG

methacholine challenge test

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Respimat® A 4

Intervention Type: DEVICE

Methacholine Chloride

Intervention Type: DRUG

methacholine challenge test

Sub-Study

Group Type: EXPERIMENTAL

Methacholine Chloride

Intervention Type: DRUG

methacholine challenge test

Spiriva

Intervention Type: DRUG

Interventions

BEA 2180 BR

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Respimat® A 4

Intervention Type: DEVICE

Methacholine Chloride

methacholine challenge test

Intervention Type: DRUG

Spiriva

Intervention Type: DRUG

Other Intervention Names

tiotropium bromide

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1205.9001

Identifier Type: OTHER

Identifier Source: secondary_id

1205.1

Identifier Type: -

Identifier Source: org_study_id