A Study in Healthy People to Test How Well Repeated Doses of BI 3032950 Are Tolerated

Last updated: November 19, 2024
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

BI 3032950

Placebo matching BI 3032950

Clinical Study ID

NCT05985200
1486-0002
U1111-1289-1904
2023-503332-40-00
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising intravenous doses of BI 3032950 in healthy male subjects and postmenopausal or surgically sterilised female subjects (women not of child bearing potential (WNOCBP)).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy male subjects and female subjects not of child bearing potential (women notof child bearing potential (WNOCBP)) - postmenopausal or surgically sterilisedfemale subjects according to the assessment of the investigator, as based on acomplete medical history including a physical examination, vital signs (bloodpressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinicallaboratory tests

  2. Age of 18 to 65 years (inclusive)

  3. Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)

  4. Signed and dated written informed consent in accordance with Internationalconference on harmonisation-good clinical practice (ICH-GCP) and local legislationprior to admission to the trial

  5. Male subjects (including male subjects with pregnant partners) who meet any of thecriteria listed in the protocol for a highly effective contraception from the firstadministration of trial medication until the end of study (EoS) visit.

  6. Postmenopausal or surgically sterilised female subjects (WNOCBP) who are:

  • Confirmed surgically sterilised (including hysterectomy, bilateralsalpingectomy and bilateral oophorectomy), or

  • Postmenopausal, defined as at least 1 year of spontaneous amenorrhea without analternative medical cause Further inclusion criteria apply.

Exclusion

Exclusion Criteria:

  1. Any finding in the medical examination (including BP, PR or ECG) deviating fromnormal and assessed as clinically relevant by the investigator

  2. Repeated measurement of systolic blood pressure outside the range of 90 to 140millimetre mercury (mmHg), diastolic blood pressure outside the range of 50 to 90mmHg, or pulse rate outside the range of 45 to 100 beats per minute (bpm); in caseof documented 'white coat hypertension' the decision for eligibility is left to theinvestigator

  3. Any laboratory value outside the reference range that the investigator considers tobe of clinical relevance

  4. Any evidence of a concomitant disease assessed as clinically relevant by theinvestigator Further exclusion criteria apply.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: BI 3032950
Phase: 1
Study Start date:
September 15, 2023
Estimated Completion Date:
August 19, 2024

Connect with a study center

  • SGS Life Science Services - Clinical Research

    Edegem, 2650
    Belgium

    Site Not Available

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