Safety, Tolerability and Pharmacodynamics of BIIX 1 XX in Healthy Young Male Volunteers

Study Overview
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Brief Summary
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The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data

Official Title
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A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Methacholine Challenge) Study After Inhalational Administration of BIIX 1 XX (Single Doses: 5 - 800 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIIX 1 XX - single rising dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers who have Broca-Indices within +-20% Participants in the age range between 21 to 50 years Following the methacholine challenge the airway resistance (Raw) shows an increase of at least 130% In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study As part of the screening (within 14 days before drug administration), each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG) Haematopoietic, hepatic and renal function test will be carried out in the laboratory The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance Exclusion Criteria: Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Volunteers with diseases of the central nervous system (such as epilepsy) or with 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 one month before enrolment in the study Use of any drugs which might influence the results of the trial the week previous to the start of the study Participation in another study with an investigational drug within the last two months preceding this study Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) Inability to refrain from smoking on study days Alcohol abuse (> 60g/day) Drug abuse Blood donation within the last 4 weeks Excessive physical activities within the last week before the study

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

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIX 1 XX - single rising dose<br> | Drug: BIIX 1 XX - single rising dose<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | up to 3 months | 
| Number of subjects with abnormal changes in laboratory parameters |  | up to 8 days after last drug administration | 
| Change in impedance cardiography |  | up to 30 minutes after drug administration | 
| Change in cutaneous microcirculation |  | up to 30 minutes after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in airway resistance (Raw) after methacholine challenge |  | up to 30 minutes after drug administration | 
| Change in specific conductance (sGaw) after methacholine challenge |  | up to 30 minutes after drug administration | 
| AUC (Area under the concentration-time curve of the analyte in plasma) |  | up to 168 hours after drug administration | 
| Cmax (Maximum measured concentration of the analyte in plasma) |  | up to 168 hours after drug administration | 
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) |  | up to 168 hours after drug administration | 
| Ae (Amount of analyte that is eliminated in urine) |  | up to 48 hours after drug administration | 
| MRT (Mean residence time of the analyte in the body) |  | up to 168 hours after drug administration | 
| t½ (Terminal half-life of the analyte in plasma) |  | up to 168 hours after drug administration | 
| CL/F(Apparent clearance of the analyte in plasma following extravascular administration) |  | up to 168 hours after drug administration |