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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT02211950

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 44847 Drug: Acarbose Other: Japanese diet	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A single dose BI 44847 administered to white subjects	Drug: BI 44847
Experimental: Treatment B 100 mg acarbose for 2 days, on the second day a single dose BI 44847 administered to white subjects	Drug: BI 44847 Drug: Acarbose Other Names: Glucobay
Experimental: Treatment C single dose BI 44847 after a Japanese diet of 6 days administered to white subjects	Drug: BI 44847 Other: Japanese diet
Experimental: Treatment D single dose BI 44847 administered to asian subjects	Drug: BI 44847
Experimental: Treatment E single dose BI 44847 administered to african subjects	Drug: BI 44847

Outcome Measures

Primary Outcome Measures

AUC0-∞ (area under the concentration time curve of the analyte in plasma in plasma over the time interval from 0 to infinity) [up to 48 hours after drug administration]
AUC0-48 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 48 h) [up to 48 hours after drug administration]
AUC0-12 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 12 h) [up to 48 hours after drug administration]
Cmax (maximum concentration of the analyte in plasma) [up to 48 hours after drug administration]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT02211950

Other Study ID Numbers:

1224.22

First Posted:

Aug 8, 2014

Last Update Posted:

Aug 8, 2014

Last Verified:

Aug 1, 2014

Additional relevant MeSH terms:

Acarbose

Study Results

No Results Posted as of Aug 8, 2014