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

Healthy Clinical Trial

Official 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05985200
• Other study ID #: 1486-0002
• Secondary ID: U1111-1289-19042
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 5, 2023
• Est. completion date: August 19, 2024

Study information

• Verified date: May 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 19, 2024
• Est. primary completion date: August 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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

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 International conference on harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial

5. 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.

6. 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:

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

2. 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

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 3032950
BI 3032950
• Placebo matching BI 3032950
Placebo matching BI 3032950

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	Occurrence of any treatment-emergent adverse event		Up to Day 137
Secondary	Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator		Up to Day 137
Secondary	Area under the concentration-time curve of the analyte in serum over a uniform dosing interval t (AUCt,)		From Day 22 to Day 134
Secondary	Maximum measured concentration of the analyte in serum (Cmax)		From Day 22 to Day 134

External Links

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