Healthy
Conditions
Brief summary
The main objective of this trial is to investigate the effect of carbamazepine, a strong CYP3A4 inducer on the pharmacokinetics of verducatib at steady state.
Interventions
DRUGVerducatib
Verducatib
DRUGCarbamazepine
Carbamazepine
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants receive verducatib in the treatment period 1 and continue for the treatment period 2 to receive verducatib and carbamazepine.
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male trial participant according to the assessment of the Investigator, as based on a complete medical history including physical examination, vital signs (blood pressure, heart rate), 12-lead electrocardiogram, clinical laboratory tests and columbia-suicide severity rating scale (C-SSRS) 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 international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
Exclusion criteria
1. Any finding in the medical examination, including blood pressure, pulse rate or electrocardiogram, as well as neurological examination and skin inspection 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 50 to 90 beats per minute 3. Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance, particularly including but not limited to haematological parameters such as haemoglobin, serum iron, leucocyte- and platelet count, hepatic parameters such as alanine aminotransferase (ALT), aspartate aminotransfrrase (AST), gamma-glutamyl transferase (GGT) and total bilirubin or renal parameters such as e.g. creatinine at screening, electrolyte disturbances, particularly hyponatremia 4. Any evidence of a concomitant disease assessed as clinically relevant by the Investigator 5. Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) | Up to 40 days. |
| Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) | Up to 40 days. |
Secondary
| Measure | Time frame |
|---|---|
| Minimum concentration of the analyte in plasma at steady state within a uniform dosing interval τ (Cmin,ss) | Up to 40 days. |
Countries
Germany
Contacts
CONTACTBoehringer Ingelheim
Outcome results
None listed