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Recruiting NCT07526194

A Study in Healthy Men to Test How Well Different Doses of BI 3821001 Are Tolerated

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BI 3821001, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Single-blind, Randomised, Placebo-controlled, Parallel Group Design Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BI 3821001 Administered to Healthy Trial Participants

Overview

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3821001 in healthy male trial participants.

Interventions

  • Drug BI 3821001
    BI 3821001
  • Drug Placebo
    Placebo

Primary outcome measures

  • Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator [Time frame: Up to 60 days]
Secondary outcome measures (3)
  • Area under the concentration-time curve of the analyte in blood over the time interval from 0 extrapolated to infinity (AUC0-∞) [Time frame: Up to 60 days]
  • Maximum measured concentration of the analyte in blood (Cmax) [Time frame: Up to 60 days]
  • Percentage of participants treated with investigational drug who experience a treatment-emergent adverse event [Time frame: Up to 60 days]

Eligibility criteria

Inclusion criteria

  • Healthy male trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
  • Age of 18 to 55 years (inclusive)
  • Body mass idnex (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply

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 50 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 Further exclusion criteria apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • CRS Clinical Research Services Berlin GmbH — Berlin

Identifiers

NCT: NCT07526194 · 2007-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗