Clinical trial NCT02211924: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 44847 Administered to Healthy Male Subjects
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (50 mg to 800 mg) of BI 44847 as Tablet(s) Administered to Healthy Male Subjects. A Randomised, Placebo-controlled (Within Dose Groups) and Double-blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-08
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 44847 in Japanese healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Subjects will be healthy male volunteers who meet the criteria below:

  * Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
  * Persons who are 20 or older and 35 or younger
  * Persons with a BMI 18.5 kg/m2 or more and 25.0 kg/m2 less
  * Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with Good Clinical Practice

Exclusion Criteria:

* Any finding of the medical examination (including BP, Pulse Rate (PR) and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of any drugs within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within four 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 (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL) within four weeks prior to administration or during the trial
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre 19. A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
* The use of concomitant medications that prolong the QT/QTc interval
* Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval \>120 ms
* Elevated urinary glucose levels at screening (\>15 mg/dl)

Primary outcomes:
measure: Number of patients with clinically relevant changes in vital signs
timeFrame: up to day 7
measure: Number of patients with clinically relevant finding in 12-lead electrocardiogram (ECG)
timeFrame: up to day 7
measure: Number of patients with clinically relevant changes in laboratory parameters
timeFrame: up to day 7
measure: Number of patients with adverse events
timeFrame: up to 5 weeks
Secondary outcomes:
measure: Cmax (maximum concentration of the analyte in plasma)
timeFrame: up to 48 hours after drug administration
measure: tmax (time from dosing to maximum concentration)
timeFrame: up to 48 hours after drug administration
measure: AUC0-inf. (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 48 hours after drug administration
measure: %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
timeFrame: up to 48 hours after drug administration
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
timeFrame: up to 48 hours after drug administration
measure: λz (terminal rate constant in plasma)
timeFrame: up to 48 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma
timeFrame: up to 48 hours after drug administration
measure: MRTpo (mean residence time of the analyte in the body after po administration)
timeFrame: up to 48 hours after drug administration
measure: CL/F (total clearance of the analyte in the plasma after extravascular administration)
timeFrame: up to 48 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
timeFrame: up to 48 hours after drug administration
measure: Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
timeFrame: up to 48 hours after drug administration
measure: fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
timeFrame: up to 48 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 48 hours after drug administration
measure: Area under the plasma glucose concentration time curve
timeFrame: up to 12 hours after drug administration
measure: Total amount of glucose excreted in the urine
timeFrame: up to 48 hours after drug administration
measure: Maximum glucose concentration in plasma
timeFrame: up to 12 hours after drug administration
measure: Maximum glucose concentration in urine
timeFrame: up to 48 hours after drug administration
Other outcomes:
Locations:
Study officials:
References: