Clinical trial NCT02266498: Pharmacokinetics of BIBB 515 BS and Effect of Food After Oral Administration in Healthy Subjects
Official title: Single-dose Pharmacokinetics of 2.5 mg BIBB 515 BS and Effect of Food After Oral Administration of Capsules to Healthy Subjects (Randomized, 2-way-cross-over, Open Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-17
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules


Eligibility criteria: Inclusion Criteria:

* Healthy male caucasian subjects as determined by results of screening
* Written informed consent in accordance with good clinical practice (GCP) and local legislation
* Age ≥ 18 and ≤ 50 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 neurologic 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 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 the 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 \> 100 ml (≤ 4 weeks prior to administration or during the trial)
* Excessive physical activities (≤ 10 days prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance

Primary outcomes:
measure: Maximum concentration of the analyte in plasma (Cmax)
timeFrame: Up to 48 hours after drug administration
measure: Time to reach maximum concentration of the analyte in plasma (tmax)
timeFrame: Up to 48 hours after drug administration
measure: Apparent terminal elimination half-life of the analyte in plasma (t1/2)
timeFrame: Up to 48 hours after drug administration
measure: Area under the concentration-time curve of the analyte in plasma at different time points (AUC)
timeFrame: Up to 48 hours after drug administration
measure: Total 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 after extravascular multiple dose administration (CL/f)
timeFrame: Up to 48 hours after drug administration
measure: Apparent volume of distribution of the analyte during the terminal phase (Vz/f)
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: Number of patients with adverse events
timeFrame: Up to 48 hours after last drug administration
measure: Global clinical assessment by the investigator
timeFrame: Day 3 after last drug administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: