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

NCT02161432 | Completed Phase 1

• 2 other identifiers: 1307.32013-004627-37
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) of BI 187004

  up to 17 days postdose

• Cmax (maximum measured concentration of the analyte in plasma) of BI 187004

  up to 17 days postdose

Secondary Outcomes (1)

• AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 17 days postdose

Study Arms (3)

Treatment A

EXPERIMENTAL

single dose of BI 187004 in fasted state

Drug: BI 187004

Treatment B

EXPERIMENTAL

single dose of BI 187004

Drug: BI 187004

Treatment C

EXPERIMENTAL

single dose of BI 187004 in fed state

Drug: BI 187004

Interventions

BI 187004 DRUG

single dose BI 187004 given as tablet in fed state

Treatment C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
• Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1307.3.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 11, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

DE (1)