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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 3032950; Drug: Placebo matching BI 3032950

• Registration Number: NCT05985200
• Lead Sponsor: Boehringer Ingelheim

Brief 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)).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-14
• Study Start: 2023-09-15
• Primary Completion: 2024-08-19
• Study Completion: 2024-08-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 3032950: Dose group 4	BI 3032950	-
BI 3032950: Dose group 2	BI 3032950	-
BI 3032950: Dose group 3	BI 3032950	-
Placebo	Placebo matching BI 3032950	-
BI 3032950: Dose group 1	BI 3032950	-

Primary Outcome Measures

Name	Time	Method
Occurrence of any treatment-emergent adverse event	Up to Day 137

Secondary Outcome Measures

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

Trial Locations

Locations (1)

SGS Life Science Services - Clinical Research; 🇧🇪 Edegem, Belgium