Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising of BEA 2180 BR in Japanese Healthy Male Volunteers

NCT02254109 | Completed Phase 1

• 1 other identifier: 1205.18
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese healthy volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Number of subjects with abnormal findings in physical examination

  up to 28 days after last dose administration

• Number of subjects with clinically significant changes in vital signs

  Blood pressure and pulse rate

  up to 28 days after last dose administration

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

  up to 28 days after last dose administration

• Number of subjects with abnormal changes in laboratory parameters

  up to 28 days after last dose administration

• Number of subjects with adverse events

  up to 28 days after last dose administration

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

  28 days after last dose administration

Secondary Outcomes (17)

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

  up to 648:00 hours

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

  up to 648:00 hours

• AUCτ (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ)

  up to 648:00 hours

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)

  up to 648:00 hours

• Aeτ (amount of analyte that is eliminated in urine over a uniform dosing interval τ)

  up to 648:00 hours

Study Arms (2)

BEA 2180 BR - rising dose

EXPERIMENTAL

Drug: BEA 2180 BR - rising dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BEA 2180 BR - rising dose DRUG

BEA 2180 BR - rising dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Japanese men:
• According to the results of a complete medical history, the physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory tests
• Age ≥20 and ≤35 years
• Body mass index (BMI) ≥18.5 and ≤25 kg/m2
• Subjects must be able to inhale medication in a competent manner from the Respimat®
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP)

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• 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 drug or its excipients
• Intake of drugs with a long half-life (\>24 hours) within one month or less than 10 half-lives of the respective drug before drug administration or during the trial
• Use of prescription or non-prescription drugs within 10 days before drug Administration or during the trial. However, over-the-counter (OTC) drugs for external application (such as lubricant eye drops for contact lens, insect bite reliever) shall be allowed
• Participation in another trial with an investigational drug within four months before drug 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 (≥60 g/day: corresponds to ca. 3 large bottles of beer, 3 gous (ca. 540 cc) of Japanese sake, 6 shots of whisky, 6 glasses of wine or 6 glasses of Japanese shochu, distilled alcoholic beverage)
• Drug abuse

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: April 1, 2008
• Primary Completion: October 1, 2008
• Last Updated: October 1, 2014

Record last verified: 2014-09