A Phase I, Randomized, Open-label, 3 or 4-period, 7-treatment, Single-dose, Two Cohort, Crossover Study to Assess the Relative Bioavailability of Laroprovstat/Rosuvastatin Fixed Combination Drug Products to the Single Therapy Products in Healthy Adults
AstraZeneca
Summary
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.
Description
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study-specific procedures. * Healthy male and female participants aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. * All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, in addition to a barrier method, to avoid pregnancy from the time of first ad…
Interventions
- DrugLaroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 1
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.
- DrugLaroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 1
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.
- DrugLaroprovstat Dose X/Rosuvastatin Dose 1 FCDP test formulation 2
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.
- DrugLaroprovstat Dose X/Rosuvastatin Dose 2 FCDP test formulation 2
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.
- DrugLaroprovstat Dose X STP
Laroprovstat Dose X STP will be administered as an oral tablet in the morning on Day 1 of a given treatment period.
Locations (2)
- Research SiteGlendale, California
- Research SiteBrooklyn, Maryland