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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 765080; Drug: Placebo

• Registration Number: NCT04666922
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-14
• Study Start: 2021-01-14
• Primary Completion: 2021-08-25
• Study Completion: 2021-08-25
• Status Verified: 2023-07
• Results First Submitted: 2023-07-14
• Results First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Results First Posted: 2024-02-23
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 mg BI 765080	BI 765080	BI 765080
10 mg BI 765080	BI 765080	BI 765080
25 mg BI 765080	BI 765080	BI 765080
50 mg BI 765080	BI 765080	BI 765080
Placebo group	Placebo	Placebo group
100 mg BI 765080	BI 765080	BI 765080
200 mg BI 765080	BI 765080	BI 765080

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Drug-related Adverse Events	Up to 87 days	Percentage of subjects with drug-related adverse events is presented.

Secondary Outcome Measures

Name	Time	Method
Maximum Measured Concentration of BI 765080 in Serum (Cmax)	Within 3 hours (h) prior to administration of BI 765080 and 30 minutes (min), 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 144h, 312h, 480h, 648h, 1320h and 1992h after administration of BI 765080.	Maximum measured concentration of BI 765080 in serum (Cmax) is presented.
Area Under the Concentration-time Curve of BI 765080 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	Within 3 hours (h) prior to administration of BI 765080 and 30 minutes (min), 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 144h, 312h, 480h, 648h, 1320h and 1992h after administration of BI 765080.	Area under the concentration-time curve of BI 765080 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented.

Trial Locations

Locations (1)

SGS Life Science Services - Clinical Research; 🇧🇪 Edegem, Belgium