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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02161432
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 187004; Drug: BI 187004; Drug: BI 187004	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Bioavailability of the Tablet Formulation (a Randomised, Open-label, Single Dose, Three-way Crossover Trial in Healthy Subjects)
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A single dose of BI 187004 in fasted state	Drug: BI 187004; single dose BI 187004 given as tablet in fasted state
Experimental: Treatment B single dose of BI 187004	Drug: BI 187004; single dose BI 187004 given as oral solution
Experimental: Treatment C single dose of BI 187004 in fed state	Drug: BI 187004; single dose BI 187004 given as tablet in fed state

Outcome Measures

Primary Outcome Measures

1. 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]

2. Cmax (maximum measured concentration of the analyte in plasma) of BI 187004 [up to 17 days postdose]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1307.3.1 Boehringer Ingelheim Investigational Site	Biberach		Germany

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02161432
• Other Study ID Numbers: 1307.3; 2013-004627-37
• First Posted: Jun 11, 2014
• Last Update Posted: Jan 27, 2016
• Last Verified: Jan 1, 2016

Study Results

No Results Posted as of Jan 27, 2016