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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 1060469 fed

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

Group Type EXPERIMENTAL

BI 1060469

Intervention Type DRUG

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

Other: standard breakfast

Intervention Type DRUG

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

BI 1060469 fasted

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

Group Type EXPERIMENTAL

BI 1060469

Intervention Type DRUG

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

Interventions

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BI 1060469

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

Intervention Type DRUG

BI 1060469

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

Intervention Type DRUG

Other: standard breakfast

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes