A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed C… (NCT04024501) | Clinical Trial Compass
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 range18 Years – 50 Years
SexALL
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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.
✕. Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of verinurad.
✕. History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
What they're measuring
1
Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC)
Timeframe: Day 1: Pre-dose and up to 72-hour Post-dose
2
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
3
Maximum Observed Plasma Concentration (Cmax) for the Analysis of PK Parameter
Timeframe: Day 1: Pre-dose and up to 72-hour Post-dose
. Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator at screening and first admission, including: (1) Alanine aminotransferase (ALT) \> 1.5 x upper limit of normal (ULN), (2) Aspartate aminotransferase (AST) \> 1.5 x ULN, (3) Bilirubin (total) \> 1.5 x ULN, (4) Gamma glutamyl transpeptidase (GGT) \> 1.5 x ULN. (5) If any of these tests are out-of-range, the tests can be repeated once.
✕. Any clinically significant abnormal findings in vital signs at the Screening Visit and/or admission to the Clinical Unit, including, but not limited to, any of the following:
✕. ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) interval corrected for heart rate using Fridericia's formula (QTcF) \> 450 ms or \< 340 ms or family history of long QT syndrome,