Clinical trial NCT05075772: A Study in Healthy Men to Test How BI 765080 is Taken up in the Body When Given as an Injection Under the Skin Compared With an Infusion Into the Vein
Official title: Absolute Bioavailability, Safety, Tolerability, and Pharmacodynamics Following Subcutaneous (SC) Injection of 100 mg BI 765080 Relative to Intravenous (IV) Dose in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-10-13
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study in healthy man to investigate the absolute bioavailability of 100mg BI 765080, once administered as subcutaneous (SC) injection and once administered as intravenous infusion.


Eligibility criteria: Inclusion Criteria:

* Healthy Caucasian male subjects according to the assessment of the investigator, as based on a complete medical history, a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12- lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good clinical practice (GCP) and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (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 assessed 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 Further exclusion criteria apply.

Primary outcomes:
measure: Area Under the Concentration-time Curve of BI 765080 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
timeFrame: Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h*, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. * Applicable only for the arm "100 mg BI 765080 SC injection (T)"
measure: Maximum Measured Concentration of BI 765080 in Plasma (Cmax)
timeFrame: Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h*, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. * Applicable only for the arm "100 mg BI 765080 SC injection (T)".
Secondary outcomes:
measure: Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
timeFrame: Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h*, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. * Applicable only for the arm "100 mg BI 765080 SC injection (T)".
measure: Occurrence of Drug-related Adverse Events
timeFrame: From start of drug of administration until end of trial, up to 59 days.
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: SGS Life Science Services - Clinical Research
Study officials:
References: