This is a Randomized, Open-Label, Single Oral Dose, Three-Way Cross-Over Trial to Evaluate the Relative Bioavailability of CVN424 Suspension and Tablet Formulations in Healthy Volunteers Under Fasted and Fed Conditions.
32 healthy male or female participants will be enrolled in 1 of 6 sequences (designated as 1 through 6, respectively) in an ascending fashion. Sequences 1, 3, 4, and 5 will have 5 participants each, and Sequences 2 and 6 will have 6 participants each. Each sequence will proceed through the three cross-overs (suspension-fasted, tablet-fed, and tablet-fasted) according to the schematic, with dosing to occur on Days 1 of Periods 1, 2, and 3. Participants in the fasted portion of each sequence will be dosed under overnight fasted conditions and will remain fasted for 4 hours post-dose. Water consumption is permitted as desired except for 1 hour before and after administration of the Study Drug. To assess the effect of food on CVN424 bioavailability in tablet formulation, the single dose will be administered after ingestion of a standardized high-fat, high-calorie meal according to FDA Guidance for Industry (Food-effect bioavailability and fed bioequivalence studies, Jun 2022). Participants for all sequences will be admitted to the study unit 1 day prior to dosing and remain in the unit for safety and pharmacokinetics (PK) assessments through 96 hours post-dose. The total confinement period will be 5 nights for each period unless extended at the discretion of the Investigator, e.g., for monitoring and/or management of adverse events (AEs). Once 96-hour post-dose PK has been collected, participants will be discharged from the unit for the remainder of the washout period and return the day prior for their next scheduled dosing period
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
32
150 mg of either tablet or suspension formulation
Celerion
Tempe, Arizona, United States
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Measured Non Zero Concentration (AUC0-t) of CVN424 Suspension Fasted and Tablet Fasted
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose
Area Under the Plasma Concentration Time Curve From Time 0 to 96 Hours (AUC 0-96h) of CVN424 Suspension Fasted and Tablet Fasted
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of CVN424 Suspension Fasted and Tablet Fasted
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose
Time to Reach Cmax (Tmax) of CVN424 Suspension and Tablet
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose
Time Taken for Drug to Appear in Systemic Circulation Following Administration (Tlag) of CVN424 Suspension and Tablet
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose
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AUC(0-t) of CVN424 Tablet Fed and Tablet Fasted
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose
AUC(0-96 Hrs) of CVN424 Tablet Fed and Tablet Fasted
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose
Cmax of CVN424 Tablet Fed and Tablet Fasted
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose
Tmax of CVN424 Tablet Fed and Tablet Fasted
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose
Tlag of CVN424 Tablet Fed and Tablet Fasted
Blood samples were collected at indicated time points for PK analysis of CVN424 tablet. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60,72, 84 and 96 hours post-dose
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs)
An adverse event is any untoward medical occurrence in a clinical research study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug.
Time frame: Up to Day 35