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

NCT02225626 | Completed Phase 1

• 2 other identifiers: 1333.442014-001960-37
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 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 6 days after last drug administration

Study Arms (2)

BI 1060469 fed

EXPERIMENTAL

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

Drug: BI 1060469; Drug: Other: standard breakfast

BI 1060469 fasted

EXPERIMENTAL

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

Drug: BI 1060469

Interventions

BI 1060469 DRUG

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

BI 1060469 fasted

Other: standard breakfast DRUG

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

BI 1060469 fed

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1333.44.1 Boehringer Ingelheim Investigational Site

Ingelheim, 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: August 25, 2014
• First Posted: August 26, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

DE (1)