Clinical trial NCT02256709: Safety, Tolerability and Pharmacokinetics of Oral BIBP 5371 CL in Healthy Male and Female Volunteers
Official title: Safety, Tolerability and Pharmacokinetics of BIBP 5371 CL Following Oral Administration to Healthy Male and Female Volunteers (Dose Range: 10 - 350 mg). A Double-blind (Within Treatment Groups), Randomised, Placebo-controlled, Single Rising Dose Study, Including Comparisons of 50 mg vs. 100 mg Tablet and Tablet vs. Drinking Solution, and Investigation of Food Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 70
Sex: ALL
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: Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers
* Age 21 - 50 years
* Body mass index (BMI) 18.5 - 29.9 kg/m2

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate, respiratory rate, body temperature and ECG) deviating from normal
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system or psychiatric disorders or neurological disorders
* History of relevant 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) within at least 1 month or less than 10 half-lives of the respective drug before enrolment in the study
* Use of any drugs which might influence the results of the trial (within 1 week prior to administration or during the trial)
* Participation in another trial with an investigational drug (within 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 trial days
* Alcohol abuse (\> 60 grams/day)
* Drug abuse
* Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial)
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range of clinical relevance

In addition, for female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. oral contraceptives, intrauterine device, sterilisation

Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least 1 month after release from the study

* Inability to maintain this adequate contraception during the whole study period
* Lactation period

Primary outcomes:
measure: Number of patients with changes in vital signs
timeFrame: baseline, up to 8 days after drug administration
measure: Number of patients with changes in electrocardiogram (ECG)
timeFrame: baseline, up to 8 days after drug administration
measure: Number of patients with changes in safety laboratory parameters
timeFrame: baseline, up to 8 days after drug administration
measure: Number of patients with adverse events
timeFrame: baseline, up to 8 days after drug administration
measure: Global tolerability assessment by the investigator on a verbal rating scale
timeFrame: up to 8 days after drug administration
Secondary outcomes:
measure: Cmax (maximum concentration of the analyte in plasma)
timeFrame: up to 32 hours after drug administration
measure: tmax (time from dosing to maximum concentration)
timeFrame: up to 32 hours after drug administration
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 32 hours after drug administration
measure: %AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)
timeFrame: up to 32 hours after drug administration
measure: λz (terminal rate constant in plasma)
timeFrame: up to 32 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
timeFrame: up to 32 hours after drug administration
measure: MRTpo (mean residence time of the analyte in the body after po administration)
timeFrame: up to 32 hours after drug administration
measure: CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
timeFrame: up to 32 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
timeFrame: up to 32 hours after drug administration
measure: Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
timeFrame: up to 32 hours after drug administration
measure: fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
timeFrame: up to 32 hours after drug administration
measure: CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
timeFrame: up to 32 hours after drug administration
Other outcomes:
Locations:
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