The purpose of this study is to assess how well laroprovstat and rosuvastatin combined in a single tablet to be taken by mouth works compared with laroprovstat and rosuvastatin individual tablets taken by mouth (relative bioavailability) in healthy adults.
This is a randomized, open-label, 3 or 4-period, single-dose, two-cohort, multi-center, crossover study. The study will comprise of a screening period (21 Days), 3 or 4 treatment periods (depending on cohort assignment) and washout period (14 Days, starting after dosing on Study Day 1 of a given treatment period). Each treatment period consists of dosing on Day 1; any subsequent treatment period will not start sooner than 14 days following dosing in the previous treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Laroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Research Site
Glendale, California, United States
Research Site
Brooklyn, Maryland, United States
Area under concentration time curve from time 0 to infinity (AUCinf)
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2)
Time frame: At predefined intervals from Day 1 to Day 11
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2).
Time frame: At predefined intervals from Day 1 to Day 11
Maximum observed drug concentration (Cmax)
To evaluate the relative bioavailability between the FCDP test formulation 1 and the STPs of laroprovstat and rosuvastatin across the planned rosuvastatin dose range, Dose 1 (Cohort 1) to Dose 2 (Cohort 2)
Time frame: At predefined intervals from Day 1 to Day 11
Terminal rate constant (λz)
To examine the PK profiles of laroprovstat and rosuvastatin when administered as FCDP test formulation 1 or STPs.
Time frame: At predefined intervals from Day 1 to Day 11
Time to reach maximum observed concentration (tmax)
To examine the PK profiles of laroprovstat and rosuvastatin when administered as FCDP test formulation 1 or STPs.
Time frame: At predefined intervals from Day 1 to Day 11
Terminal elimination half life (t1/2λz)
To examine the PK profiles of laroprovstat and rosuvastatin when administered as FCDP test formulation 1 or STPs.
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Laroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2 will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Laroprovstat Dose X STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Rosuvastatin Dose 1 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Rosuvastatin Dose 2 STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Time frame: At predefined intervals from Day 1 to Day 11
Apparent total body clearance (CL/F)
To examine the PK profiles of laroprovstat and rosuvastatin when administered as FCDP test formulation 1 or STPs.
Time frame: At predefined intervals from Day 1 to Day 11
Apparent volume of distribution based on the terminal phase (V/F)
To examine the PK profiles of laroprovstat and rosuvastatin when administered as FCDP test formulation 1 or STPs.
Time frame: At predefined intervals from Day 1 to Day 11
AUCinf
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Time frame: At predefined intervals from Day 1 to Day 11
AUClast
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Time frame: At predefined intervals from Day 1 to Day 11.
Cmax
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Time frame: At predefined intervals form Day 1 to Day 11
tmax
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Time frame: At predefined intervals from Day 1 to Day 11
λz
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Time frame: At predefined intervals form Day 1 to Day 11
t1/2λz
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Time frame: At predefined intervals from Day 1 to Day 11.
CL/F
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Time frame: At predefined intervals form Day 1 to Day 11
V/F
To examine the effect on the PK profiles of laroprovstat and rosuvastatin when administered as an FCDP test formulation 1 with high fat meal compared to when administered as an FCDP test formulation 1 in the fasted state.
Time frame: At predefined intervals from Day 1 to Day 11