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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06081530
• Other study ID #: 1517-0001
• Secondary ID: 2023-504538-23-0
• Status: Recruiting
• Phase: Phase 1
• Start date: October 24, 2023
• Est. completion date: October 22, 2024

Study information

• Verified date: December 2023
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: October 22, 2024
• Est. primary completion date: October 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 3802876
BI 3802876
• Placebo matching BI 3802876
Placebo matching BI 3802876

Locations

Country	Name	City	State
Belgium	SGS Life Science Services - Clinical Research	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Part A: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-8)		up to Day 35
Secondary	Part A: Maximum measured concentration of the analyte in serum (Cmax)		up to Day 35
Secondary	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 (AUCt,ss)		up to Day 106
Secondary	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

External Links

•   Related Info