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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BEA 2180 BR - rising dose; Drug: Placebo

• Registration Number: NCT02254109
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-10
• Status Verified: 2014-09
• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-09-30
• Last Update Submitted: 2014-09-30
• Study First Posted: 2014-10-01
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

1. 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

2. Age ≥20 and ≤35 years

3. Body mass index (BMI) ≥18.5 and ≤25 kg/m2

4. Subjects must be able to inhale medication in a competent manner from the Respimat®

5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP)

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Exclusion Criteria

1. Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance

2. Any evidence of a clinically relevant concomitant disease

3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

4. Surgery of the gastrointestinal tract (except appendectomy)

5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

6. History of relevant orthostatic hypotension, fainting spells or blackouts

7. Chronic or relevant acute infections

8. History of relevant allergy/hypersensitivity including allergy to drug or its excipients

9. 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

10. 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

11. Participation in another trial with an investigational drug within four months before drug administration or during the trial

12. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)

13. Inability to refrain from smoking during the trial

14. 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)

15. Drug abuse

16. Blood donation (≥100 mL within four weeks before drug administration or during the trial)

17. Excessive physical activities (within one week before drug administration or during the trial)

18. Any laboratory value outside the reference range that is of clinical relevance

19. Inability to comply with dietary regimen of trial site

    Exclusion criteria specific for this study:

20. Occupational (professional) exposure to antimuscarinic substances (e.g., physician, nurse, pharmacist etc.; volunteers working for medical institutions, research institutions or herb gardens)

21. History of glaucoma, urination difficulty (due to prostatic hyperplasia etc.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BEA 2180 BR - rising dose	BEA 2180 BR - rising dose	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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	up to 28 days after last dose administration	Blood pressure and pulse rate
Number of subjects with clinically significant changes in 12-lead electrocardiogram (ECG)	up to 28 days after last dose administration
Number of subjects with adverse events	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
Assessment of tolerability by the investigator on a 4-point scale	28 days after last dose administration

Secondary Outcome Measures

Name	Time	Method
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
feτ (fraction of analyte eliminated in urine over a uniform dosing interval τ)	up to 648:00 hours
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)	up to 648:00 hours
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)	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
λz,ss (terminal rate constant in plasma at steady state)	up to 648:00 hours
Accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax)	up to 648:00 hours
Cmin,ss (minimum concentration of the analyte in plasma at steady state)	up to 648:00 hours
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)	up to 648:00 hours
t1/2,ss (terminal half-life of the analyte in plasma at steady state)	up to 648:00 hours
MRTih,ss (mean residence time of the analyte in the body at steady state after inhalation administration)	up to 648:00 hours
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)	up to 648:00 hours
Accumulation ratio of the analyte in plasma based on AUC (RA,AUC)	up to 648:00 hours
Accumulation ratio of the analyte in plasma based on Ae (RA,Ae)	up to 648:00 hours