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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 1060469; Drug: BI 1060469; Drug: Other: standard breakfast

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Ingelheim, Germany
    • 1333.44.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 of water after an overnight fast of at least 10 h; 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; Drug: BI 1060469; tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 25, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (Estimate): August 26, 2014

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 10, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 1333.44; 2014-001960-37 (EudraCT Number: EudraCT)