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

NCT02211950 | Completed Phase 1

• 1 other identifier: 1224.22
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• 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

Study Arms (5)

Treatment A

EXPERIMENTAL

single dose BI 44847 administered to white subjects

Drug: BI 44847

Treatment B

EXPERIMENTAL

100 mg acarbose for 2 days, on the second day a single dose BI 44847 administered to white subjects

Drug: BI 44847; Drug: Acarbose

Treatment C

EXPERIMENTAL

single dose BI 44847 after a Japanese diet of 6 days administered to white subjects

Drug: BI 44847; Other: Japanese diet

Treatment D

EXPERIMENTAL

single dose BI 44847 administered to asian subjects

Drug: BI 44847

Treatment E

EXPERIMENTAL

single dose BI 44847 administered to african subjects

Drug: BI 44847

Interventions

BI 44847 DRUG

Treatment A; Treatment B; Treatment C; Treatment D; Treatment E

Acarbose DRUG

Also known as: Glucobay

Treatment B

Japanese diet OTHER

Treatment C

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Acarbose

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 8, 2014
• Study Start: October 1, 2008
• Primary Completion: December 1, 2008
• Last Updated: August 8, 2014

Record last verified: 2014-08