A Study in Healthy People to Test How Well Repeated Doses of BI 3032950 Are Tolerated
- Conditions
- Healthy
- Registration Number
- NCT05985200
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:<br><br> 1. Healthy male subjects and female subjects not of child bearing potential (women not<br> of child bearing potential (WNOCBP)) - postmenopausal or surgically sterilised<br> female subjects according to the assessment of the investigator, as based on a<br> complete medical history including a physical examination, vital signs (blood<br> pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical<br> laboratory tests<br><br> 2. Age of 18 to 65 years (inclusive)<br><br> 3. Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)<br><br> 4. Signed and dated written informed consent in accordance with International<br> conference on harmonisation-good clinical practice (ICH-GCP) and local legislation<br> prior to admission to the trial<br><br> 5. Male subjects (including male subjects with pregnant partners) who meet any of the<br> criteria listed in the protocol for a highly effective contraception from the first<br> administration of trial medication until the end of study (EoS) visit.<br><br> 6. Postmenopausal or surgically sterilised female subjects (WNOCBP) who are:<br><br> - Confirmed surgically sterilised (including hysterectomy, bilateral<br> salpingectomy and bilateral oophorectomy), or<br><br> - Postmenopausal, defined as at least 1 year of spontaneous amenorrhea without an<br> alternative medical cause Further inclusion criteria apply.<br><br>Exclusion Criteria:<br><br> 1. Any finding in the medical examination (including BP, PR or ECG) deviating from<br> normal and assessed as clinically relevant by the investigator<br><br> 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140<br> millimetre mercury (mmHg), diastolic blood pressure outside the range of 50 to 90<br> mmHg, or pulse rate outside the range of 45 to 100 beats per minute (bpm); in case<br> of documented 'white coat hypertension' the decision for eligibility is left to the<br> investigator<br><br> 3. Any laboratory value outside the reference range that the investigator considers to<br> be of clinical relevance<br><br> 4. Any evidence of a concomitant disease assessed as clinically relevant by the<br> investigator Further exclusion criteria apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of any treatment-emergent adverse event
- Secondary Outcome Measures
Name Time Method Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator;Area under the concentration-time curve of the analyte in serum over a uniform dosing interval t (AUCt,);Maximum measured concentration of the analyte in serum (Cmax)