Clinical trial NCT02211950: Relative Bioavailability of BI 44847 in Different Ethnic Groups and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers
Official title: Evaluation of Relative Bioavailability of BI 44847 in Different Ethnic Groups (Subjects of White, Asian, and African Origin), and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers. An Open-label, Single-dose, Parallel Group, Phase 1 Study (Group 1 With Additional Crossover Aspects)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-08
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives were to investigate the relative bioavailability of BI 44847 in different racial groups (white, Asian, and African subjects) and to investigate the effect of different types of diet and acarbose coadministration on the bioavailability of BI 44847 in white subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects determined by results of screening
* Age 18 - 40 years
* Body Mass Index 18 - 25 kg/m2, at least 45 kg
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator
* Relevant gastrointestinal tract surgery
* Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or relevant neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, pulse rate out of 45 to 90 beats per minute
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
* 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 within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation
* Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study
* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
* Inability to refrain from smoking when confined to the study site on trial days
* Alcohol abuse (more than 60 g/day in males, more than 40 g/day in females)
* Drug abuse, in the investigator's judgment upon review of the patient's history and urine screening for abused substances
* Veins unsuited for iv puncture on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture)
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within 48 hours prior to trial or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance according to the assessment of the investigator
* Inability to comply with dietary regimen of study centre
* Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

Primary outcomes:
measure: AUC0-∞ (area under the concentration time curve of the analyte in plasma in plasma over the time interval from 0 to infinity)
timeFrame: up to 48 hours after drug administration
measure: AUC0-48 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 48 h)
timeFrame: up to 48 hours after drug administration
measure: AUC0-12 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 12 h)
timeFrame: up to 48 hours after drug administration
measure: Cmax (maximum concentration of the analyte in plasma)
timeFrame: up to 48 hours after drug administration
Secondary outcomes:
measure: tmax (time from dosing to maximum concentration of the analyte in plasma)
timeFrame: up to 48 hours after drug administration
measure: λz (terminal rate constant in plasma after single dose
timeFrame: up to 48 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma after single dose)
timeFrame: up to 48 hours after drug administration
measure: MRTpo (mean residence time of the analyte in the body after single dose)
timeFrame: up to 48 hours after drug administration
measure: CL/F (apparent clearance of the analyte in the plasma after extravascular administration after single dose)
timeFrame: up to 48 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz after single dose following extravascular administration)
timeFrame: up to 48 hours after drug administration
measure: AUCt1-t2 (area under the concentration time curve of analyte in plasma over the time interval t1 to t2)
timeFrame: up to 24 hours after drug administration
measure: Aet1-t2 (amount of drug that is eliminated in urine from the time point t1 to time point t2)
timeFrame: up to 24 hours after drug administration
measure: fet1-t2 (fraction of drug eliminated in urine from time point t1 to time point t2)
timeFrame: up to 24 hours after drug administration
measure: CLR,t1-t2 (renal clearance of the drug from the time point t1 until the time point t2)
timeFrame: up to 24 hours after drug administration
measure: Amount of glucose excreted in urine
timeFrame: up to 24 hours after drug administration
measure: Number of patients with adverse events
timeFrame: up to 48 hours after last administration of study drug
measure: Number of patients with clinically relevant changes in laboratory tests
timeFrame: up to 48 hours after last administration of study drug
measure: Number of patients with clinically relevant changes in Electrocardiogram (ECG)
timeFrame: up to 48 hours after last administration of study drug
measure: Number of patients with clinically relevant changes in vital signs
timeFrame: up to 48 hours after last administration of study drug
measure: Assessment of global tolerability by investigator on a 4-point scale
timeFrame: 48 hours after last administration of study drug
Other outcomes:
Locations:
Study officials:
References: