Safety, Tolerability and Pharmacodynamics After Oral Administration of BIIF 1149 BS in Healthy Male Volunteers

Study Overview
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Brief Summary
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The objective of the study is to obtain information about the safety and tolerability of BIIF 1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic data.

Official Title
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A Single Increasing Dose Safety, Tolerability and Pharmacodynamics (Citric Acid Challenge) Study After Oral Administration of BIIF 1149 BS (Single Doses as Tablets: 40, 65, 100 mg) in Healthy Male Volunteers (Randomised, Double-blind Within Each Dose Group, Placebo-controlled, Parallel Groups)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIIF 1149 BS
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males, based on a complete medical examination Age range from 21 to 50 years +/- 20 % of their normal weight (Broca-Index) Written informed consent 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 Volunteers with known history of orthostatic hypotension, fainting spells or blackouts Volunteers with chronic or relevant acute infections (especially respiratory infections, cough) Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study Volunteers who received any other drugs which might influence the results of the study during the week prior to the start of the study Volunteers who have participated in another study with an investigational drug within the last 2 months preceding this study Volunteers who smoke more than 10 cigarettes (or equivalent) per day Volunteers who are not able to refrain from smoking on study days Volunteers who drink more than 40 g of alcohol per day Volunteers who are dependent on drugs Volunteers who are participated in excessive physical activities (e.g. competitive sports) during the last week before the study Volunteers who have donated blood (≥ 100 ml) within the last four weeks

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIF 1149 BS<br> | Drug: BIIF 1149 BS<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 patients with clinically relevant changes in vital functions (blood pressure, pulse rate) |  | up to 8 days after last drug administration | 
| Number of patients with clinically relevant changes in electrocardiogram (ECG) |  | up to 8 days after last drug administration | 
| Number of patients with clinically relevant changes in laboratory parameters |  | up to 8 days after last drug administration | 
| Number of patients with adverse events |  | up to 8 days after last drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum drug plasma concentration (Cmax) |  | up to 360 hours after drug administration | 
| Time to reach maximum drug concentration (tmax) |  | up to 360 hours after drug administration | 
| Total area under the plasma drug concentration-time curve (AUC) for several time points |  | up to 360 hours after drug administration | 
| Terminal half-life (t1/2) |  | up to 360 hours after drug administration | 
| Mean residence time (MRT) |  | up to 360 hours after drug administration | 
| Total clearance after oral administration (CLtot/f) |  | up to 360 hours after drug administration | 
| Amount of drug excreted in urine (Ae) |  | up to 360 hours after drug administration | 
| Measurement of pharmacodynamic activity | Citric acid challenge | Screening, at least 15 days after first administration | 
| Volume of Distribution during terminal phase after oral administration (Vz/F) |  | up to 360 hours after drug administration | 
| Renal clearance in the time interval form 0 to x h (Clren0-xh) |  | up to 360 hours after drug administration |