Clinical trial NCT02208856: Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses Oral BIRB 796 BS in Healthy Human Subjects
Official title: Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (1, 4, 15, 50, 100, 200, 400, and 600 mg) Oral BIRB 796 BS in Healthy Human Subjects. A Placebo Controlled, Randomised Study, Double Blinded at Each Dose Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single doses, with and without a 64 g fat breakfast at one selected dose.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
* Age \>= 18 and \<= 45 years
* Broca \>= -20% and \<= +20%

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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 ot the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (= 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial (= 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (=2 months prior to administration or during trial)
* Smoker (\> 10 cigarettes of \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation \> 400 ml (=1 month prior to administration of during the trial)
* Excessive physical activities (= 5 days prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance (but not exclusive to) total white cell count \>= 10 x 10\*\*9/L, C-reactive protein \>= 4.5 mg/L, any haemoglobin or \> 15 mg/dl protein on urine dipstick
* History of any familial bleeding disorder

Primary outcomes:
measure: Number of subjects with clinically relevant changes in vital signs
timeFrame: Baseline, up to 96 hours after drug administration
measure: Number of subjects with clinically relevant changes in laboratory measurements
timeFrame: Baseline, up to 96 hours after drug administration
measure: Number of subjects with clinically relevant changes in electrocardiograms (ECG)
timeFrame: Baseline, up to 96 hours after drug administration
measure: Number of subjects with adverse events
timeFrame: up to 96 hours after drug administration
Secondary outcomes:
measure: Maximum concentration of the analyte in plasma (Cmax)
timeFrame: up to 48 hours after drug administration
measure: Area under the concentration-time curve of the analyte in plasma from time zero to infinity (AUC0-inf)
timeFrame: up to 48 hours after drug administration
measure: Time from dosing to the maximum concentration of the analyte in plasma (Tmax)
timeFrame: up to 48 hours after drug administration
measure: Terminal rate constant of the analyte in plasma (λz)
timeFrame: up to 48 hours after drug administration
measure: Half life of the analyte in plasma (t1/2)
timeFrame: up to 48 hours after drug administration
measure: Mean residence time of the analyte in the body (MRTtot)
timeFrame: up to 48 hours after drug administration
measure: Apparent clearance of the analyte in plasma (CL/F)
timeFrame: up to 96 hours after drug administration
measure: Apparent volume of distribution during the terminal phase λz (Vz/F)
timeFrame: up to 48 hours after drug administration
measure: Mac-1/L selectin ratio of formyl-methionyl-leucyl-phenylalanine (fMLP)-stimulated to unstimulated neutrophils
timeFrame: up to 48 hours after drug administration
measure: Mac-1/L selectin ratio of TNFalpha-stimulated to unstimulated neutrophils
timeFrame: up to 48 hours after drug administration
measure: Percent changes in TNFalpha production
timeFrame: up to 48 hours after drug administration
Other outcomes:
Locations:
Study officials:
References: