Clinical trial NCT02209714: Safety, Tolerability and Pharmacodynamics After Oral Administration of BIIF 1149 BS in Healthy Male Volunteers
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 24
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with clinically relevant changes in vital functions (blood pressure, pulse rate)
timeFrame: up to 8 days after last drug administration
measure: Number of patients with clinically relevant changes in electrocardiogram (ECG)
timeFrame: up to 8 days after last drug administration
measure: Number of patients with clinically relevant changes in laboratory parameters
timeFrame: up to 8 days after last drug administration
measure: Number of patients with adverse events
timeFrame: up to 8 days after last drug administration
Secondary outcomes:
measure: Maximum drug plasma concentration (Cmax)
timeFrame: up to 360 hours after drug administration
measure: Time to reach maximum drug concentration (tmax)
timeFrame: up to 360 hours after drug administration
measure: Total area under the plasma drug concentration-time curve (AUC) for several time points
timeFrame: up to 360 hours after drug administration
measure: Terminal half-life (t1/2)
timeFrame: up to 360 hours after drug administration
measure: Mean residence time (MRT)
timeFrame: up to 360 hours after drug administration
measure: Total clearance after oral administration (CLtot/f)
timeFrame: up to 360 hours after drug administration
measure: Amount of drug excreted in urine (Ae)
timeFrame: up to 360 hours after drug administration
measure: Measurement of pharmacodynamic activity
timeFrame: Screening, at least 15 days after first administration
measure: Volume of Distribution during terminal phase after oral administration (Vz/F)
timeFrame: up to 360 hours after drug administration
measure: Renal clearance in the time interval form 0 to x h (Clren0-xh)
timeFrame: up to 360 hours after drug administration
Other outcomes:
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