A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 765080

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 765080; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04666922

2020-004262-19 (EudraCT Number)

1450-0001

Details and patient eligibility

About

The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 765080 in healthy male subjects following intravenous administration of single rising doses.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
• Age of 18 to 50 years (inclusive)
• 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 GCP and local legislation

Exclusion criteria

• Any finding in the medical examination (including BP, PR or 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 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
• A positive poly chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and clinical symptoms suggestive for this disease on Day -2.
• Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 7 patient groups, including a placebo group

1 mg BI 765080

Experimental group

Description:

BI 765080

Treatment:

Drug: BI 765080

Placebo group

Placebo Comparator group

Description:

Placebo group

Treatment:

Drug: Placebo

10 mg BI 765080

Experimental group

Description:

BI 765080

Treatment:

Drug: BI 765080

25 mg BI 765080

Experimental group

Description:

BI 765080

Treatment:

Drug: BI 765080

50 mg BI 765080

Experimental group

Description:

BI 765080

Treatment:

Drug: BI 765080

100 mg BI 765080

Experimental group

Description:

BI 765080

Treatment:

Drug: BI 765080

200 mg BI 765080

Experimental group

Description:

BI 765080

Treatment:

Drug: BI 765080