Study to Evaluate the Pharmacokinetics of Oral Sparsentan (QSC200850)
Research type
Research Study
Full title
A Three Way Sequential, Randomised, Open Label Study Designed to Evaluate the Single- and Multiple Dose Pharmacokinetics and the Effect of Food on the Single Dose Pharmacokinetics of Oral Sparsentan Suspension in Healthy Subjects
IRAS ID
281068
Contact name
Michelle Greenman
Contact email
Sponsor organisation
Retrophin, Inc.
Eudract number
2020-001159-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
Summary of Research\n\nThe Sponsor, Retrophin Inc, is developing a new formulation of the test medicine, sparsentan, for the potential treatment of focal segmental glomerulosclerosis (FSGS - disease in which scar tissue develops on the kidney parts that filter waste from the blood) and immunoglobulin A nephropathy (IgAN - a build up of kidney deposits, causing inflammation that damages kidney tissues).\n\nFSGS and IgAN are serious conditions that can lead to kidney failure, where the only treatment options currently are dialysis or kidney transplant. Current formulations of sparsentan in development are capsules/tablets, yet as FSGS and IgAN can affect children, a new formulation of sparsentan in the form of an oral suspension is being developed.\n\nThis study aims to identify the blood levels of sparsentan after single doses with and without food and after multiple doses at 3 different dose levels. The safety and tolerability and acceptability of the new suspension formulation will also be assessed.\n\nThis is a single-part, single-centre study consisting of three study periods involving up to 48 healthy male and female (of non-childbearing potential) volunteers. Volunteers will be randomised into 3 treatment groups that will all follow the same study design. Each treatment group will receive a different dose of the test medicine throughout the study.\n\nVolunteers will be admitted to the clinic on the day before dosing (Day -1). In periods 1 and 2, all treatment groups will receive a single dose of the test medicine in the fed or fasted state and for period 3, all treatment groups will receive multiple doses of the test medicine for 14 consecutive days in the fed state. Volunteers will be discharged on Day 28 and will receive a follow up phone call 5-7 days after their final dose of the test medicine, to check on their health and wellbeing.\n\nSummary of Results\n\nGiven that this is a phase 1 trial, no lay summary of results has been provided for reasons of commercial confidentiality
REC name
Wales REC 2
REC reference
20/WA/0110
Date of REC Opinion
14 May 2020
REC opinion
Favourable Opinion