Healthy
Conditions
Brief summary
The main objective of this trial is to evaluate the effects of verducatib in the range of therapeutic to supra-therapeutic exposures on the QT/QTc-interval and other ECG parameters
Interventions
DRUGVerducatib
Verducatib
DRUGMoxifloxacin
Moxifloxacin
DRUGPlacebo resembling Verducatib
Placebo resembling Verducatib
DRUGPlacebo resembling Moxifloxacin
Placebo resembling Moxifloxacin
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 and female trial participants 2. Aged 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 blood pressure (BP), heart rate (HR) or electrocardiogram (ECG), deviating from normal and assessed as clinically relevant by the Investigator 2. Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or pulse rate (PR) outside the range of 50 to 90 bpm 3. Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance, including but not limited to increased hepatic parameters, electrolyte disturbances, particularly hypokalemia and hypomagnesemia 4. Any evidence of a concomitant disease assessed as clinically relevant by the Investigator Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QT-interval corrected for heart rate, e.g. using the method of Fridericia change from baseline (ΔQTcF), paired with the verducatib plasma concentrations | Up to day 31 | ΔQTcF defined as the time-matched QTcF change from baseline, paired with the verducatib plasma concentrations collected at the same timepoints up to a maximum of 30 days after first drug administration of verducatib/verducatib-placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QT-interval corrected for heart rate, e.g. using the method of Fridericia change from baseline (ΔQTcF), paired with the moxifloxacin plasma concentrations | Up to day 31 | ΔQTcF, defined as the QTcF change from baseline, paired with the moxifloxacin plasma concentrations collected at the same timepoints up to 24 hours after a single dose administration of moxifloxacin/moxifloxacin-placebo and constitutes the assessment of assay sensitivity in this trial |
Countries
Germany
Contacts
CONTACTBoehringer Ingelheim
Outcome results
None listed