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Completed

NCT Number: NCT05985200

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

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)).

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects and female subjects not of child bearing potential (women not of child bearing potential (WNOCBP)) - postmenopausal or surgically sterilised female subjects 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 65 years (inclusive)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
  • Signed and dated written informed consent in accordance with International conference on harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
  • Male subjects (including male subjects with pregnant partners) who meet any of the criteria listed in the protocol for a highly effective contraception from the first administration of trial medication until the end of study (EoS) visit.
  • Postmenopausal or surgically sterilised female subjects (WNOCBP) who are:
  • Confirmed surgically sterilised (including hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or
  • Postmenopausal, defined as at least 1 year of spontaneous amenorrhea without an alternative medical cause 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 millimetre mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 100 beats per minute (bpm); in case of documented 'white coat hypertension' the decision for eligibility is left to the investigator
  • 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.

Treatment and study plan

BI 3032950

Drug

BI 3032950

Placebo matching BI 3032950

Drug

Placebo matching BI 3032950

Primary outcomes

  1. Occurrence of any treatment-emergent adverse event

    Time frame: Up to Day 137

Secondary outcomes

  1. Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

    Time frame: Up to Day 137

  2. Area under the concentration-time curve of the analyte in serum over a uniform dosing interval τ (AUCτ,)

    Time frame: From Day 22 to Day 134

  3. Maximum measured concentration of the analyte in serum (Cmax)

    Time frame: From Day 22 to Day 134

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 3032950 in Healthy Male and Female Subjects (Single-blind, Randomised Within Dose Groups, Placebo-controlled Parallel-group Design)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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