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

NCT02263976 | Completed Phase 1

• 2 other identifiers: 1205.11205.9001
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (7)

• Number of subjects with clinically significant changes in vital signs

  blood pressure, pulse rate, respiratory rate, oral body temperature

  up to 14 days after last drug administration

• Number of subjects with clinically significant changes in laboratory parameters

  up to 14 days after last drug administration

• Changes from baseline in airway resistance (Raw)

  assessed by body plethysmography

  up to 120 hours after drug administration

• Changes from baseline in specific airway conductance (sGaw)

  assessed by body plethysmography

  up to 120 hours after drug administration

• Number of subjects with clinically significant findings in 12-lead ECG (electrocardiogram)

  up to 14 days after last drug administration

• Number of subjects with adverse events

  up to 14 days after last drug administration

• Assessment of tolerability by investigator on a 5-point scale

  within 14 days after last drug administration

Secondary Outcomes (14)

• Changes from baseline in salivary secretion

  up to 24 hours after drug administration

• Changes from baseline in pupil diameter of each eye

  up to 4 hours after drug administration

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to 240 hours after drug administration

• Measured concentration of the analyte in plasma (C) for several time points

  up to 24 hours after drug administration

• Time from dosing to the maximum concentration of the analyte in plasma (tmax)

  up to 240 hours after drug administration

Study Arms (3)

BEA 2180 BR

EXPERIMENTAL

single rising doses

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

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Device: Respimat® A 4; Drug: Methacholine Chloride

Sub-Study

EXPERIMENTAL

Drug: Methacholine Chloride; Drug: Spiriva

Interventions

BEA 2180 BR DRUG

BEA 2180 BR

Placebo DRUG

Placebo

Respimat® A 4 DEVICE

BEA 2180 BR; Placebo

Methacholine Chloride DRUG

methacholine challenge test

BEA 2180 BR; Placebo; Sub-Study

Spiriva DRUG

Also known as: tiotropium bromide

Sub-Study

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Methacholine Chloride; Tiotropium Bromide

Intervention Hierarchy (Ancestors)

Methacholine Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; 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 13, 2014
• First Posted: October 15, 2014
• Study Start: August 1, 2003
• Primary Completion: June 1, 2004
• Last Updated: October 15, 2014

Record last verified: 2014-10