CompletedPhase 1

A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed Condition

Germany25 participantsStarted 2019-07-20

Plain-language summary

This study is intended to assess the relative bioavailability between the (extended-release) ER8 capsule formulation (the formulation that is currently used for verinurad development) given under fasted conditions and 2 new capsule formulations of verinurad (A-capsule and B-capsule) given under fed or fasted conditions. All three capsules target an 8-hour release profile (extended-release). The highest dose (12 mg) currently tested in participants will be tested in this study. The study is designed to provide information to optimize the verinurad part of a fixed dose combination capsule to be used in future development.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of signed and dated, written informed consent prior to any study specific procedures.
. Healthy male and female participants aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
. Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
. Females must have a negative pregnancy test at screening and on admission to the unit and must be:

Exclusion criteria

. History of gout or any clinically significant disease or disorder which, in the opinion of the Principal Investigator (PI), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC)

Timeframe: 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

Timeframe: Day 1: Pre-dose and up to 72-hour Post-dose

Maximum Observed Plasma Concentration (Cmax) for the Analysis of PK Parameter

Timeframe: Day 1: Pre-dose and up to 72-hour Post-dose

Trial details

NCT IDNCT04024501

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-18

Results submitted2020-08-04

View on ClinicalTrials.gov More Chronic Kidney Disease trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of signed and dated, written informed consent prior to any study specific procedures.
. Healthy male and female participants aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
. Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
. Females must have a negative pregnancy test at screening and on admission to the unit and must be:

Exclusion criteria

. History of gout or any clinically significant disease or disorder which, in the opinion of the Principal Investigator (PI), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.

What they're measuring

Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC)

Timeframe: 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

Timeframe: Day 1: Pre-dose and up to 72-hour Post-dose

Maximum Observed Plasma Concentration (Cmax) for the Analysis of PK Parameter

Timeframe: Day 1: Pre-dose and up to 72-hour Post-dose