Healthy
Conditions
Brief summary
To assess pharmacokinetics, safety, and tolerability of multiple oral doses of verducatib in healthy Chinese male and female trial participants in order to facilitate the clinical development of verducatib in China.
Interventions
DRUGVerducatib
Verducatib
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female trial participants 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), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests * Age of 18 to 55 years (inclusive) * BMI of 18.5 to 28 kg/m2 (inclusive) * Signed and dated written informed consent in accordance with International Council on Harmonization - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * Further inclusion criteria apply
Exclusion criteria
* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator * 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 50 to 100 beats per minute (bpm) * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease assessed as clinically relevant by the investigator * Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of the analyte in plasma from time point 0 to time point 24 h after administration of the first dose (AUC0-24) | At 24 hours |
| Maximum measured concentration of the analyte in plasma after administration of the first dose (Cmax) | At 24 hours |
| Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) | Up to Day 64 |
| Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) | Up to Day 64 |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of treatment emergent adverse events during the trial | Up to Day 65 |
Countries
China
Outcome results
None listed