A Study in Healthy Men to Test How Well Different Doses of BI 3802876 Are Tolerated

Single-blind, Randomised, Placebo-Controlled Trial on the Safety, Tolerability, and Pharmacokinetics of Single Rising Doses and Multiple Doses of Intravenous BI 3802876 in Healthy Subjects

The main objective of this trial is to investigate the safety, tolerability, and pharmacokinetics of BI 3802876 when administered in different doses in healthy male volunteers. The primary objective is to descriptively assess the frequency of drug-related adverse events (AEs) in subjects treated with BI 3802876, as compared to placebo. The secondary objective is to descriptively assess pharmacokinetic parameters.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 3802876; Drug: Placebo matching BI 3802876

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Recruiting
    • SGS Life Science Services - Clinical Research
    • Contact: Boehringer Ingelheim; Phone Number: 080049616; Email: belgique@bitrialsupport.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (temperature, blood pressure, pulse), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of ≥18 to ≤55 years at screening
3. Body mass index (BMI) of ≥ 19.0 to ≤ 32.0 kg/m2 at screening. A minimum body weight of 65 kg at screening
4. Signed and dated written informed consent prior to admission to the study, in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation

Exclusion Criteria:

1. Any finding in the medical examination (including blood pressure (BP), pulse rate, or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Three repeated measurements of systolic BP outside the range of 90 to 140 mm Hg, diastolic BP outside the range of 50 to 90 millimetre of mercury (mmHg), or pulse outside the range of 50 to 90 beats per minute. In case of documented white coat hypertension, the decision for eligibility is left to the investigator.
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator

Further exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Part A: Placebo	Drug: Placebo matching BI 3802876; Placebo matching BI 3802876
Placebo Comparator: Part B: Placebo	Drug: Placebo matching BI 3802876; Placebo matching BI 3802876
Experimental: Part A: BI 3802876 dose group 1	Drug: BI 3802876; BI 3802876
Experimental: Part A: BI 3802876 dose group 2	Drug: BI 3802876; BI 3802876
Experimental: Part A: BI 3802876 dose group 3	Drug: BI 3802876; BI 3802876
Experimental: Part A: BI 3802876 dose group 4	Drug: BI 3802876; BI 3802876
Experimental: Part A: BI 3802876 dose group 5	Drug: BI 3802876; BI 3802876
Experimental: Part A: BI 3802876 dose group 6	Drug: BI 3802876; BI 3802876
Experimental: Part B: BI 3802876	Drug: BI 3802876; BI 3802876

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part A and Part B: Occurrences of any drug-related AEs between first drug administration (BI 3802876 or placebo) and end of the residual effect period (REP)	up to Day 35 for Part A and up to Day 106 for Part B

Secondary Outcome Measures

Outcome Measure	Time Frame
Part A: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)	up to Day 35
Part A: Maximum measured concentration of the analyte in serum (Cmax)	up to Day 35
Part B: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state, if steady state can be reasonably assumed (AUCτ,ss)	up to Day 106
Part B: Maximum measured concentration of the analyte in serum at steady state, if steady state can be reasonably assumed (Cmax,ss)	up to Day 106

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): October 22, 2024
• Study Completion (Estimated): October 22, 2024

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1517-0001; 2023-504538-23-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No