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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BEA 2180 BR solution for infusion; Drug: Placebo; Device: Respimat®; Drug: BEA 2180 BR solution for inhalation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02254720

1205.5

Details and patient eligibility

About

Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of BEA 2180 BR; additional exploration of metabolism following inhalation

Enrollment: 71 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12 lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
2. Age ≥21 and ≤50 years
3. BMI ≥18.5 and <29.9 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria

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

2. Evidence of a clinically relevant concomitant disease

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

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

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

6. Chronic or relevant acute infections

7. History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator

8. Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation

9. 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 enrolment in the study or during the study

10. Participation in another trial with an investigational drug within 2 months prior to randomisation

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

12. Inability to refrain from smoking on trial days as judged by the investigator

13. Alcohol abuse (regularly more than 40 g alcohol per day for men)

14. Drug abuse

15. Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)

16. Excessive physical activities within 1 week prior to randomisation or during the trial

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

18. Inability to comply with dietary regimen of the study centre

    The following exclusion criteria are specific for this study due to the known class side effect profile of anticholinergic drugs:

19. hypersensitivity to tiotropium and/or related drugs of these classes

20. history of narrow-angle glaucoma

21. history of prostatic hyperplasia

22. history of bladder-neck obstruction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 3 patient groups, including a placebo group

BEA 2180 BR IV

Experimental group

Description:

Rising doses

Treatment:

Drug: BEA 2180 BR solution for infusion

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

BEA 2180 BR inhalation

Experimental group

Treatment:

Drug: BEA 2180 BR solution for inhalation

Device: Respimat®