Healthy
Conditions
Brief summary
The main objective of this trial is to investigate the effect of vicadrostat on the heart compared with placebo in healthy male and female volunteers.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female trial participant 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 50 years (inclusive) 3. Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive) 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum mean difference between each single dose of either low or high dose of vicadrostat and placebo in QTcF changes from baseline between 20 min to 24 hours after drug administration | at baseline, up to 24 hours | QT interval is the electrocardiogram (ECG) interval from the start of the QRS complex to the end of the T wave QTcF: QT interval corrected for heart rate using the method of Fridericia |
Secondary
| Measure | Time frame |
|---|---|
| The maximum mean difference between moxifloxacin and placebo in QTcF changes from baseline between 20 min to 24 hours after drug administration | at baseline, up to 24 hours |
Countries
Germany
Contacts
CONTACTBoehringer Ingelheim
Outcome results
None listed