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Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers

NCT ID: NCT02161432

Last Updated: 2016-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-09-30

Brief Summary

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To determine the relative bioavailability of an BI 187004 tablet formulation compared to an oral solution of BI 187004 and to assess the influence of food on the bioavailability of the tablet formulation.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

single dose of BI 187004 in fasted state

Group Type EXPERIMENTAL

BI 187004

Intervention Type DRUG

single dose BI 187004 given as tablet in fasted state

Treatment B

single dose of BI 187004

Group Type EXPERIMENTAL

BI 187004

Intervention Type DRUG

single dose BI 187004 given as oral solution

Treatment C

single dose of BI 187004 in fed state

Group Type EXPERIMENTAL

BI 187004

Intervention Type DRUG

single dose BI 187004 given as tablet in fed state

Interventions

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BI 187004

single dose BI 187004 given as tablet in fed state

Intervention Type DRUG

BI 187004

single dose BI 187004 given as tablet in fasted state

Intervention Type DRUG

BI 187004

single dose BI 187004 given as oral solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male subjects
2. Age of 18 to 50 years
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2

Exclusion Criteria

1. Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1307.3.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2013-004627-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1307.3

Identifier Type: -

Identifier Source: org_study_id

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