Clinical trial NCT02211157: Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets Administered to Healthy Human Subjects
Official title: Safety, Pharmacokinetics and Pharmacodynamics of BIRB 796 BS Tablets (20, 30, 150, 300, and 600 mg) Administered Orally to Healthy Human Subjects Once Daily for 7 Days. A Placebo Controlled, Randomised, Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-07
Enrollment: 24
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: Study to assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating multiple doses with and without a 64 g fat breakfast at the 50 mg dose level


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice and local legislation
* Age ≥ 18 and ≤ 45 years
* Broca ≥ - 20% and ≤ + 20%

Exclusion Criteria:

* Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* History of orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* 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 drugs with a long half-life (\>24 hours) within 1 month prior to administration or during the trial)
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation \> 400 ml within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the reference range of clinical relevance including, but not limited to total white cell count ≥ 10 x 10\*\*9/L, C-reactive protein ≥ 4.5 mg/L, Gamma-Glutamyl Transferase ≥ 40 U/L, any hemoglobin or \> 15 mg/dl protein or urine dipstick, abnormal Multitest® assessment of cellular immunity
* History of any familial bleeding disorder
* Inability to comply with dietary regimen of study centre

Primary outcomes:
measure: Number of patients with clinically relevant changes in laboratory parameters
timeFrame: up to day 16
measure: Number of patients with abnormal findings in electrocardiogram (ECG)
timeFrame: up to day 16
measure: Number of patients with adverse events
timeFrame: up to 30 days
measure: Assessment of tolerability on a 4-point scale
timeFrame: day 16
measure: Number of patients with clinically relevant changes in vital signs
timeFrame: up to 16 days
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) for several time points
timeFrame: up to day 9
measure: Area under the plasma concentration-time curve (AUC) for several time points
timeFrame: up to day 9
measure: Time to maximum concentration (tmax)
timeFrame: up to day 9
measure: Elimination rate constant (λz)
timeFrame: up to day 9
measure: Terminal half-life (t1/2)
timeFrame: up to day 9
measure: Mean residence time (MRT)
timeFrame: up to day 9
measure: Apparent clearance (CL/f)
timeFrame: up to day 9
measure: Apparent volume of distribution (Vz/F)
timeFrame: up to day 9
measure: Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with formyl-methionyl-leucyl-phenylalanine (fMLP)
timeFrame: up to day 9
measure: Assessment of neutrophil and monocyte activation by ex vivo stimulation of whole blood with tumour necrosis factor (TNF) α
timeFrame: up to day 9
measure: Assessment of TNFα production by ex vivo stimulation of whole blood with endotoxin
timeFrame: up to day 9
measure: Changes in cellular immune response measured by Multitest®
timeFrame: Day 8
Other outcomes:
Locations:
Study officials:
References: