Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT02225626

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male subjects as well as to investigate pharmacokinetics, safety and tolerability

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 1060469 Drug: BI 1060469 Drug: Other: standard breakfast	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 1060469 fed tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administr	Drug: BI 1060469 tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration Drug: Other: standard breakfast tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration
Experimental: BI 1060469 fasted tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h	Drug: BI 1060469 tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h

Arm

Intervention/Treatment

Experimental: BI 1060469 fed

tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administr

Drug: BI 1060469

tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration

Drug: Other: standard breakfast

tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration

Experimental: BI 1060469 fasted

tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h

Drug: BI 1060469

tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h

Outcome Measures

Primary Outcome Measures

AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [up to 6 days after last drug administration]
Cmax (maximum measured concentration of the analyte in plasma) [up to 6 days after last drug administration]
Frequency of subjects with drug-related adverse events [up to 7 days after last drug administration]

Secondary Outcome Measures

AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [up to 6 days after last drug administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

healthy male according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG, and clinical laboratory tests
Age of 18 to 50 years (incl.)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Repeated measurement of pulse rate < 50 bpm and > 90 bpm at screening
Serum creatinine laboratory value outside the normal range
estimated glomerular filtration rate (eGFR) according to CKD-EPI-Creatinine Formula < 90 ml/ min
Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
Any evidence of a concomitant disease judged as clinically relevant by the investigator Repeated measurement of pulse rate < 50 bpm and > 90 bpm at screening
Serum creatinine laboratory value outside the normal range
estimated glomerular filtration rate (eGFR) according to CKD-EPI-Creatinine Formula < 90 ml/ min
Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
Any evidence of a concomitant disease judged as clinically relevant by the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1333.44.1 Boehringer Ingelheim Investigational Site	Ingelheim		Germany

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT02225626

Other Study ID Numbers:

1333.44
2014-001960-37

First Posted:

Aug 26, 2014

Last Update Posted:

May 12, 2015

Last Verified:

May 1, 2015

Study Results

No Results Posted as of May 12, 2015