Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0123
Source ID: NCT04024501
Associated Drug: Verinurad Er8 Capsule Formulation (Fasted)
Title: A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed Condition
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04024501/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: Verinurad ER8 capsule formulation (fasted)|DRUG: Verinurad A-capsule formulation (fasted)|DRUG: Verinurad A-capsule formulation (fed)|DRUG: Verinurad B-capsule formulation (fasted)|DRUG: Verinurad B-capsule formulation (fed)
Outcome Measures: Primary: Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC), To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions., Day 1: Pre-dose and up to 72-hour Post-dose|AUC From Time 0 to the Last Quantifiable Concentration (AUC0-t) for the Analysis of PK Parameter, To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions., Day 1: Pre-dose and up to 72-hour Post-dose|Maximum Observed Plasma Concentration (Cmax) for the Analysis of PK Parameter, To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions., Day 1: Pre-dose and up to 72-hour Post-dose | Secondary: AUC From Time 0 to 24 Hours Post Dose (AUC0-24) for the Analysis of PK Parameter, To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions., Pre-dose and up to 24-hours Post-dose|Time to Reach Maximum Observed Plasma Concentration (Tmax) for the Analysis of PK Parameter, To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions., Day 1: Pre-dose and up to 72-hour Post-dose|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) for the Analysis of PK Parameter, To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions., Day 1: Pre-dose and up to 72-hour Post-dose|Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) for the Analysis of PK Parameter, To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions., Day 1: Pre-dose and up to 72-hour Post-dose|Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity (MRT) for the Analysis of PK Parameter, To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions., Day 1: Pre-dose and up to 72-hour Post-dose|Time of Last Quantifiable Plasma Concentration (Tlast) for the Analysis of PK Parameter, To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions., Day 1: Pre-dose and up to 72-hour Post-dose|Volume of Distribution at Steady State (Intravenous Dosing) (Vss/F) for the Analysis of PK Parameter, To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions., Day 1: Pre-dose and up to 72-hour Post-dose|Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for the Analysis of PK Parameter, To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions., Day 1: Pre-dose and up to 72-hour Post-dose|Number of Participants With Adverse Events (AEs), To assess AEs as variable of safety and tolerability of single doses of verinurad in healthy participants., From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 25
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-07-20
Completion Date: 2019-09-18
Results First Posted: 2020-08-21
Last Update Posted: 2021-03-18
Locations: Research Site, Berlin, 14050, Germany
URL: https://clinicaltrials.gov/show/NCT04024501