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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BEA 2180 BR - rising dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02254109

1205.18

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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)

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

BEA 2180 BR - rising dose

Experimental group

Treatment:

Drug: BEA 2180 BR - rising dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo