Trial Outcomes & Findings for 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 (NCT NCT05075772)

Last Updated: 2024-08-13

Results Overview

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) is reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome 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)"

Results posted on

2024-08-13

Participant Flow

The trial was randomized, open-label, and single-dose, with matched parallel groups (test treatment (T) group: subcutaneous (SC) injection of 100 milligram (mg) BI 765080; reference treatment (R) group: intravenous (IV) infusion of 100 mg BI 765080). Subjects in the T and R groups were matched based on age and body weight.

All subjects were screened for eligibility prior to participation in the trail. Subjects attend a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	100 mg BI 765080 SC Injection (T) Participants were administered a single dose of 100 milligram (mg) of BI 765080 as subcutaneous injection (SC).	100 mg BI 765080 IV Infusion (R) Participants were administered a single dose of 100 milligram (mg) of BI 765080 as intravenous infusion (IV).
Overall Study STARTED	14	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	100 mg BI 765080 SC Injection (T) n=14 Participants Participants were administered a single dose of 100 milligram (mg) of BI 765080 as subcutaneous injection (SC).	100 mg BI 765080 IV Infusion (R) n=14 Participants Participants were administered a single dose of 100 milligram (mg) of BI 765080 as intravenous infusion (IV).	Total n=28 Participants Total of all reporting groups
Age, Continuous	40.4 Years STANDARD_DEVIATION 12.2 • n=5 Participants	41.1 Years STANDARD_DEVIATION 10.3 • n=7 Participants	40.8 Years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Weight	81.91 kilogram (kg) STANDARD_DEVIATION 9.72 • n=5 Participants	82.92 kilogram (kg) STANDARD_DEVIATION 9.01 • n=7 Participants	82.41 kilogram (kg) STANDARD_DEVIATION 9.21 • n=5 Participants

PRIMARY outcome

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)"

Population: The pharmacokinetic (PK) parameter analysis set (PKS): Including all subjects in the treated set (TS) who provided non-excluded data for at least one primary or secondary PK endpoint. Descriptive and model-based analyses of PK parameters were based on the PKS.

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) is reported.

Outcome measures

Outcome measures
Measure	100 mg BI 765080 SC Injection (T) n=13 Participants Participants were administered a single dose of 100 milligram (mg) of BI 765080 as subcutaneous injection (SC).	100 mg BI 765080 IV Infusion (R) n=14 Participants Participants were administered a single dose of 100 milligram (mg) of BI 765080 as intravenous infusion (IV).
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)	3528304.5 hours*nanogram/milliliter Standard Error NA Adjusted geometric standard error= 1.082	7625263.8 hours*nanogram/milliliter Standard Error NA Adjusted geometric standard error= 1.079

PRIMARY outcome

Maximum measured concentration of BI 765080 in plasma (Cmax) is reported.

Outcome measures

Outcome measures
Measure	100 mg BI 765080 SC Injection (T) n=13 Participants Participants were administered a single dose of 100 milligram (mg) of BI 765080 as subcutaneous injection (SC).	100 mg BI 765080 IV Infusion (R) n=14 Participants Participants were administered a single dose of 100 milligram (mg) of BI 765080 as intravenous infusion (IV).
Maximum Measured Concentration of BI 765080 in Plasma (Cmax)	9582.0 nanogram/milliliter Standard Error NA Adjusted geometric standard error= 1.064	35718.4 nanogram/milliliter Standard Error NA Adjusted geometric standard error= 1.061

SECONDARY outcome

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.

Outcome measures

Outcome measures
Measure	100 mg BI 765080 SC Injection (T) n=13 Participants Participants were administered a single dose of 100 milligram (mg) of BI 765080 as subcutaneous injection (SC).	100 mg BI 765080 IV Infusion (R) n=14 Participants Participants were administered a single dose of 100 milligram (mg) of BI 765080 as intravenous infusion (IV).
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	3590175.4 hours*nanogram/milliliter Standard Error NA Adjusted geometric standard error= 1.080	7638615.9 hours*nanogram/milliliter Standard Error NA Adjusted geometric standard error= 1.077

SECONDARY outcome

Timeframe: From start of drug of administration until end of trial, up to 59 days.

Population: Treated Set: Included all subjects who were randomised and treated with a dose of study drug.

Percentage of participants with drug-related adverse events is reported.

Outcome measures

Outcome measures
Measure	100 mg BI 765080 SC Injection (T) n=14 Participants Participants were administered a single dose of 100 milligram (mg) of BI 765080 as subcutaneous injection (SC).	100 mg BI 765080 IV Infusion (R) n=14 Participants Participants were administered a single dose of 100 milligram (mg) of BI 765080 as intravenous infusion (IV).
Occurrence of Drug-related Adverse Events	28.6 percentage of participants	7.1 percentage of participants

Adverse Events

100 mg BI 765080 SC Injection (T)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

100 mg BI 765080 IV Infusion (R)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	100 mg BI 765080 SC Injection (T) n=14 participants at risk Participants were administered a single dose of 100 milligram (mg) of BI 765080 as subcutaneous injection (SC).	100 mg BI 765080 IV Infusion (R) n=14 participants at risk Participants were administered a single dose of 100 milligram (mg) of BI 765080 as intravenous infusion (IV).
General disorders Injection site reaction	14.3% 2/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
General disorders Medical device site irritation	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
General disorders Sense of oppression	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 2/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Musculoskeletal and connective tissue disorders Periarthritis	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Infections and infestations COVID-19	14.3% 2/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Nervous system disorders Dizziness	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	14.3% 2/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Nervous system disorders Dysgeusia	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Nervous system disorders Headache	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Gastrointestinal disorders Diarrhoea	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Investigations Electrocardiogram repolarisation abnormality	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Psychiatric disorders Abnormal dreams	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.
Psychiatric disorders Agitation	7.1% 1/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.	0.00% 0/14 • From start of drug of administration until end of trial, up to 59 days. Treated Set: Included all subjects who were randomised and treated with a dose of study drug.