Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, Icalcaprant, Itraconazole, ABBV-1354, CVL-354
Brief summary
This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of icalcaprant in healthy participants.
Interventions
DRUGIcalcaprant
Oral capsule
Oral capsule
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Exclusion criteria
* History of any clinically significant sensitivity or allergy to any medication or food. * Exposure to icalcaprant within the past 90 days. * History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant | Up to approximately 14 days | Beta of Icalcaprant |
| Terminal Phase Elimination Half-Life (t1/2) of Icalcaprant | Up to approximately 14 days | T1/2 of Icalcaprant |
| Area under the plasma concentration-time curve (AUC) of Icalcaprant | Up to approximately 14 days | AUC of Icalcaprant |
| Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant | Up to approximately 14 days | AUCt of Icalcaprant |
| Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant | Up to approximately 14 days | AUCinf of Icalcaprant |
| Maximum Observed Plasma Concentration (Cmax) of Icalcaprant | Up to approximately 14 days | Cmax of Icalcaprant |
| Time to Cmax (Tmax) of Icalcaprant | Up to approximately 14 days | Tmax of Icalcaprant |
| Number of Participants with Adverse Events (AEs) | Up to approximately 47 days | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study |
Countries
United States
Outcome results
None listed