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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06081530
Collaborator
(none)
63
Enrollment
9
Arms
12.9
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 3802876
  • Drug: Placebo matching BI 3802876
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 26, 2023
Anticipated Primary Completion Date :
Nov 22, 2024
Anticipated Study Completion Date :
Nov 22, 2024

Arms and Interventions

Arm Intervention/Treatment
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
Placebo Comparator: Part A: Placebo

Drug: Placebo matching BI 3802876
Placebo matching BI 3802876
Experimental: Part B: BI 3802876

Drug: BI 3802876
BI 3802876
Placebo Comparator: Part B: Placebo

Drug: Placebo matching BI 3802876
Placebo matching BI 3802876

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

  2. Part A: Maximum measured concentration of the analyte in serum (Cmax) [up to Day 35]

  3. 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]

  4. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT06081530
Other Study ID Numbers:
  • 1517-0001
  • 2023-504538-23-00
First Posted:
Oct 13, 2023
Last Update Posted:
Oct 17, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 17, 2023