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

NCT ID: NCT02254122

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BEA 2180 BR

Group Type: EXPERIMENTAL

BEA 2180 BR

Intervention Type: DRUG

Respimat®

Intervention Type: DEVICE

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Respimat®

Intervention Type: DEVICE

Interventions

BEA 2180 BR

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Respimat®

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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

1.1 No finding deviating from normal and of clinical relevance

1.2 No evidence of a clinically relevant concomitant disease

2. Age ≥30 and ≤55 years

3. BMI ≥18.5 and BMI < 30 kg/m2 (Body Mass Index)

4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria

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

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

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

4. Chronic or relevant acute infections

5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the Investigator

6. 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

7. 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

8. Participation in another trial with an investigational drug within two months prior to administration or during the trial

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

10. Inability to refrain from smoking during the trial

11. Alcohol abuse (more than 60 g/day)

12. Drug abuse

13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

14. Excessive physical activities (within one week prior to administration or during the trial)

15. Any laboratory value outside the reference range if indicative of underlying disease or poor health

• Asthma or chronic obstructive pulmonary disease
• Glaucoma
• Urinary tract obstruction
• Occupational (professional) exposure to antimuscarinic substances

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1205.2

Identifier Type: -

Identifier Source: org_study_id