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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 44847; Other: Japanese diet; Drug: Acarbose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02211950

1224.22

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 5 patient groups

Treatment A

Experimental group

Description:

single dose BI 44847 administered to white subjects

Treatment:

Drug: BI 44847

Treatment B

Experimental group

Description:

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

Treatment:

Drug: Acarbose

Drug: BI 44847

Treatment C

Experimental group

Description:

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

Treatment:

Drug: BI 44847

Other: Japanese diet

Treatment D

Experimental group

Description:

single dose BI 44847 administered to asian subjects

Treatment:

Drug: BI 44847

Treatment E

Experimental group

Description:

single dose BI 44847 administered to african subjects

Treatment:

Drug: BI 44847