First in-human, SAD, MAD and FE Study of ASP6858 in Healthy Subjects
Research type
Research Study
Full title
A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP6858 in Healthy Subjects
IRAS ID
167393
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Astellas Pharma Europe BV
Eudract number
2014-003735-18
Duration of Study in the UK
0 years, 5 months, 25 days
Research summary
The new medicine tested in this study is a compound called ASP6858. The Sponsor is developing the study drug for treating chronic kidney disease, with the hope of reducing the need for dialysis and to slow the progression of the disease.
The study is divided into Part 1 and Part 2. Separate groups of subjects will be included in each part of the study. The study will recruit healthy subjects between the ages of 18 and 55 years (inclusive).
Approximately 54 male subjects will take part in Part 1 of the study, additional subjects, up to a maximum of 16, may be enrolled should additional doses be needed or additional dose groups be added.
Approximately 24 male and female subjects will take part in Part 2 of the study, additional subjects, up to a maximum of 16, may be enrolled should additional doses be needed or additional dose groups be added.The main purpose of the study is to see how safe the study drug is and how well it is tolerated after single and multiple dosing. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted by the body. Part 1 will look at how this process is possibly altered by fasting, by giving the study drug in the absence of meals. The effect that the study drug has on the body (pharmacodynamics) will also be assessed, by measuring the branched amino acids levels and the 24-hour urinary
urea nitrogen (24UUN) excretion. Branched-chain amino acids are essential nutrients that the body obtains from proteins found in food.
Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples for pharmacokinetic and pharmacodynamics analysis will be collected.REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/2039
Date of REC Opinion
2 Feb 2015
REC opinion
Further Information Favourable Opinion