A Study in Healthy People to Measure the Amount of BI 655130 in the Blood After Injecting Different Doses Into Different Parts of the Body
A Study in Healthy People to Measure the Amount of BI 655130 in the Blood After Injecting Different Doses Into Different Parts of the Body
The primary objective of this trial is to investigate the relative bioavailability of BI
 655130 administered as two subcutaneous injections in the left and right periumbilical region
 compared to a single subcutaneous periumbilical injection of BI 655130.

 The secondary objective is to investigate the relative bioavailability of a single
 subcutaneous injection of BI 655130 into the thigh compared to a single subcutaneous
 periumbilical injection of BI 655130.
Inclusion Criteria:- Healthy male or female subjects 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 Electrocardiogram (ECG), and clinical
 laboratory tests

 -  Age of 18 to 50 years (incl.)

 -  Body mass index (BMI) of 19.0 to 29.9 kg/m2 (incl.)

 -  Signed and dated written informed consent prior to admission to the study in
 accordance with International Conference on Harmonisation - Good Clinical Practice
 (ICH-GCP) and local legislation

 -  Male subjects, or female subjects who meet any of the following criteria starting from
 at least 30 days before the first administration of trial medication and until 30 days
 after trial completion:

 -  Use of adequate contraception, e.g. any of the following methods plus condom:

 ---implants, injectables, combined oral or vaginal contraceptives, intrauterine
 device

 -  Sexually abstinent

 -  A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)

 -  Surgically sterilised (including hysterectomy)

 -  Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in
 questionable cases a blood sample with simultaneous levels of FSH above 40 IU/L
 and estradiol below 30 ng/L is confirmatory)

 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 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 45 to 90 beats per minute (bpm)

 -  Any laboratory value outside the reference range that the investigator considers to be
 of clinical relevance

 -  Any evidence of a concomitant disease judged as clinically relevant by the
 investigator

 -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
 immunological or hormonal disorders

 -  Diseases of the central nervous system (including but not limited to any kind of
 seizures or stroke), and other relevant neurological or psychiatric disorders

 -  History of relevant orthostatic hypotension, fainting spells, or blackouts

 -  Chronic or relevant acute infections

 -  History of relevant allergy or hypersensitivity (including allergy to the trial
 medication or its excipients)

 -  Use of drugs within 30 days prior to administration of trial medication if that might
 reasonably influence the results of the trial (incl. QT/QTc interval prolongation)

 -  Participation in another trial where an investigational drug has been administered
 within 60 days prior to planned administration of trial medication, or current
 participation in another trial involving administration of investigational drug

 -  Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)

 -  Inability to refrain from smoking on specified trial days

 -  Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for
 males)

 -  Drug abuse or positive drug screening

 -  Blood donation of more than 100 mL within 30 days prior to administration of trial
 medication or intended donation during the trial

 -  Intention to perform excessive physical activities within one week prior to
 administration of trial medication up to 4 weeks after administration

 -  Inability to comply with dietary regimen of trial site

 -  A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are
 repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females)
 or any other relevant ECG finding at screening

 -  A history of additional risk factors for Torsades de Pointes (such as heart failure,
 hypokalemia, or family history of Long QT Syndrome)

 -  Subject is assessed as unsuitable for inclusion by the investigator, for instance,
 because considered not able to understand and comply with study requirements, or has a
 condition that would not allow safe participation in the study

 Female subjects will not be allowed to participate if any of the following applies:

 -  Positive pregnancy test, pregnancy or plans to become pregnant up to study completion

 -  Lactation

 In addition, the following trial-specific exclusion criterion applies:

 - Previous use of the trial medication