Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BEA 2180 BR in Healthy Male Volunteers

NCT02254122 | Completed Phase 1

• 1 other identifier: 1205.2
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of BEA 2180 BR

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• Number of subjects with abnormal findings in physical examination

  up to day 42

• Number of subjects with clinically significant changes in vital signs

  up to day 42

• Number of subjects with clinically significant changes in 12-lead electrocardiogram

  up to day 42

• Number of subjects with clinically significant changes in laboratory parameters

  up to day 42

• Changes in effective airway resistance (Reff)

  Body plethysmography

  up to day 25

• Changes in specific effective airway conductance (SGeff)

  Body plethysmography

  up to day 25

• Changes in salivary secretion

  up to day 21

• Number of subjects with adverse events

  up to day 42

• Assessment of tolerability by the Investigator on a 4-point rating scale

  day 42

Secondary Outcomes (15)

• Maximum concentration of the analyte in plasma for several time points

  up to day 35

• Time from dosing to maximum concentration in plasma for several time points

  up to day 35

• Area under the concentration-time curve of the analyte in plasma for several time points

  up to day 35

• Amount of analyte that is eliminated in urine for several time points

  up to day 34

• Fraction of analyte excreted in urine for several time points

  up to day 34

Study Arms (2)

BEA 2180 BR

EXPERIMENTAL

Drug: BEA 2180 BR; Device: Respimat®

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Device: Respimat®

Interventions

BEA 2180 BR DRUG

BEA 2180 BR

Placebo DRUG

Placebo

Respimat® DEVICE

BEA 2180 BR; Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy males according to the following criteria (examined at the Screening Visit):
• Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
• No finding deviating from normal and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥30 and ≤55 years
• BMI ≥18.5 and BMI \< 30 kg/m2 (Body Mass Index)
• 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
• 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
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking 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 if indicative of underlying disease or poor health

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: September 30, 2014
• First Posted: October 1, 2014
• Study Start: May 1, 2004
• Primary Completion: February 1, 2005
• Last Updated: October 1, 2014

Record last verified: 2014-09