Dose Extension Study of BIIX 1 XX in Healthy Young Male Volunteers

Study Overview
=================
Brief Summary
-----------------
Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.

Official Title
-----------------
A Single Increasing Dose Safety and Tolerability Study (Dose Extension) After Inhalational Administration of BIIX 1 XX (Single Doses: 800 - 2000 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: BIIX 1 XX inhalation solution
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males, based on a complete medical examination Age range from 21 to 50 years Participant must be within +/- 20 % of their normal weight (Broca-Index) Participant must provide written informed consent Exclusion Criteria: Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) or laboratory tests deviating from normal and of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Diseases of the central nervous system (such as epilepsy) or psychiatric disorders History of orthostatic hypotension, fainting spells or blackouts Chronic or relevant acute infections History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator Intake of a drug with a long half-life (≥ 24 hours) within at least one month or less than then half-lives of the respective drug before enrolment in the study Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial Participation in another trial with an investigational drug within two months prior to start of the study Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) Inability to refrain from smoking on study days Alcohol abuse Drug abuse Blood donation (> 100 ml) within four weeks prior to administration Other disease or abnormality of clinical relevance Excessive physical activities within two weeks prior to administration or during the trial

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIX 1 XX, rising doses<br> | Drug: BIIX 1 XX inhalation solution<br>* single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 22 days | 
| Number of patients with clinically relevant changes in vital parameters (Blood pressure, Pulse rate) |  | up to 8 days after drug administration | 
| Number of patients with clinically relevant changes in electrocardiogram (ECG) |  | up to 8 days after drug administration | 
| Number of patients with clinically relevant changes in impedance cardiography |  | pre-dose, 10 and 30 minutes after administration | 
| Number of patients with clinically relevant changes in cutaneous microcirculation |  | pre-dose, 10 and 30 minutes after administration | 
| Number of patients with clinically relevant changes in safety laboratory parameters |  | up to 8 days after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration of the drug in plasma (Cmax) |  | up to 168 hours after drug administration | 
| Area under the plasma drug concentration-time curve from zero time to the last time point of measurement (AUC0-tz) |  | up to 168 hours after drug administration | 
| Terminal half-life of the analyte in plasma (t1/2) |  | up to 168 hours after drug administration | 
| Clearance, divided by f (CL/f) |  | up to 168 hours after drug administration |