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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

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ClinicalTrials.gov Identifier: NCT02211950
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

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Study Type : Interventional  (Clinical Trial)
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 : October 2008
Actual Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose

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 Name: 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



Primary Outcome Measures :
  1. AUC0-∞ (area under the concentration time curve of the analyte in plasma in plasma over the time interval from 0 to infinity) [ Time Frame: up to 48 hours after drug administration ]
  2. AUC0-48 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 48 h) [ Time Frame: up to 48 hours after drug administration ]
  3. AUC0-12 (area under the concentration time curve of the analyte in plasma over the time interval from 0 to 12 h) [ Time Frame: up to 48 hours after drug administration ]
  4. Cmax (maximum concentration of the analyte in plasma) [ Time Frame: up to 48 hours after drug administration ]

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


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02211950     History of Changes
Other Study ID Numbers: 1224.22
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Acarbose
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs