Phase I study (QSC303160)
Research type
Research Study
Full title
A Two-Part, Open-Label Study Designed to Determine the Pharmacokinetics of MDR1 and BCRP Transporter Probes (Digoxin and Rosuvastatin) Alone and in Combination with IB1001 in the Fasted State, and to Assess the Effect of Food on the Pharmacokinetics of IB1001 in Healthy Subjects
IRAS ID
1011424
Contact name
Taylor Fields
Contact email
Sponsor organisation
IntraBio Inc
ISRCTN Number
ISRCTN14080958
Research summary
The Sponsor is developing the test medicine, IB1001, as a potential treatment for rare neurological (brain and nerve) disorders including Niemann-Pick disease type C (NPC), GM2 gangliosidosis, and ataxia telangiectasia (AT).
This is a two-part study. Part 1 will assess how IB1001 interacts with two licensed medicines; Digoxin (commonly used to control heart problems) and Rosuvastatin (commonly used to treat high cholesterol). Part 2 will assess how food affects how IB1001 gets into the blood stream.
In this study in healthy volunteers, we aim to answer these questions.
*Does taking the test medicine with Digoxin and Rosuvastatin affect the blood levels of the approved medicines?
*Does food affect how the test medicine gets into the bloodstream?We also want to get more information on safety and side effects that occur.
This study will take place at 1 site in Nottingham.
We plan to enrol healthy men and women aged 18-55 years in (16 in Part 1 and 14 in Part 2).
In Part 1, volunteers will receive a single dose of digoxin and rosuvastatin, followed by a 5-day washout period. Volunteers will then receive a single dose of Digoxin and Rosuvastatin followed by a 3 times daily dose of IB1001 for 5 days. They’ll stay in the clinic for 12 nights, attend 1 outpatient visit, and take up to 7 weeks to finish the study.
In Part 2 volunteers will receive 2 single doses of IB1001; once in a fed and once in a fasted state. The order in which state they will receive these doses is selected randomly. There will be a washout period of 24 h between the doses. They’ll stay in the clinic for 3 nights, attend 1 outpatient visit and take up to 6 weeks to finish the study.
We’ll collect blood and urine samples to:
* do safety tests
* measure the amount of test medicine (Parts 1 and 2) and amounts of Digoxin and Rosuvastatin (Part 1)REC name
HSC REC B
REC reference
25/NI/0029
Date of REC Opinion
8 May 2025
REC opinion
Further Information Favourable Opinion