Clinical trial NCT02172222: Relative Bioavailability of BI 10773 and Linagliptin in Healthy Male Volunteers
Official title: Relative Bioavailability of Multiple Doses BI 10773 50 mg and Linagliptin 5 mg After Concomitant Administration Compared to Multiple Doses of BI 10773 50 mg and Linagliptin 5mg Administered Alone to Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 16
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: Study to investigate the relative bioavailability of BI 10773 and of linagliptin after concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in comparison to 50 mg BI 10773 and 5 mg linagliptin given alone.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers according to the following criteria:

  * Based upon a complete medical history and physical examination including vital signs (BP (blood pressure), PR (pulse rate)), 12-lead ECG (electrocardiogram) and clinical laboratory tests
* Age 18 to 50 years (inclusive)
* BMI 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.

Exclusion Criteria:

* Any finding of the medical examination (including BP, 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
* Surgery of the gastrointestinal tract (except appendectomy)
* 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
* Participation in another trial with an investigational drug within two 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 30 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 trial site

Primary outcomes:
measure: AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
timeFrame: up to day 8
measure: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
timeFrame: up to day 8
Secondary outcomes:
measure: tmax,ss (time from last dosing to the maximum measured concentration of each analyte in plasma at steady state)
timeFrame: up to day 8
measure: Urine glucose excretion (UGE)
timeFrame: Pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 hours after the last dosing of each visit
measure: Plasma DPP-4 (Dipeptidyl-peptidase 4) inhibition
timeFrame: 2 hours and 24 hours after last administration of study drug
measure: Changes from baseline in physical examination
timeFrame: Baseline and within 5 days after last study drug administration
measure: Changes from baseline in vital signs (blood pressure, pulse rate)
timeFrame: Baseline, day 1 and within 5 days after last study drug administration
measure: Changes from baseline in 12-lead ECG (electrocardiogram)
timeFrame: Baseline and within 5 days after last study drug administration
measure: Changes from baseline clinical laboratory tests
timeFrame: Baseline, day 1 and within 5 days after last study drug administration
measure: Incidence of adverse events
timeFrame: Up to 56 days
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: Within 5 days after last study drug administration
Other outcomes:
Locations:
Study officials:
References: