*Evaluating Effects of NST1024 on PK of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam
Research type
Research Study
Full title
A Phase 1, Open-label Study to Evaluate the Effects of NST-1024 on the Pharmacokinetics of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Subjects
IRAS ID
1005286
Contact name
Sarah Nicholson
Contact email
Sponsor organisation
NorthSea Therapeutics BV
Eudract number
2022-000730-42
Clinicaltrials.gov Identifier
Research summary
Research Summary
The Study Drug is an investigational drug being developed by the sponsor as a potential treatment for severe hypertriglyceridemia (HTG, high level of a certain type of fat [triglycerides] in the blood), mixed dyslipidaemia (abnormal fat levels in the blood) and hypercholesterolaemia (high blood cholesterol).
The current treatments for this condition have side effects or might not be very effective, and it is hoped that the Study Drug will be more effective with fewer side effects.
As of early April 2022, a total of 94 subjects have been exposed to either the Study Drug or matched placebo at doses up to 400 mg as a single dose and up to 20 mg in repeat dosing for 14 days. The Study Drug has been well-tolerated so far with few side effects.
This will be a drug-drug interaction study. The main purpose of this study is to determine whether potential interactions between the Study Drug and other drugs exist. Drug drug interaction studies have an important role in drug development, and this study is being performed as part of the development program for the Study Drug.
Summary of Results
https://clinicaltrials.gov/study/NCT05368831?intr=NST-1024&rank=3
REC name
London - Harrow Research Ethics Committee
REC reference
22/FT/0074
Date of REC Opinion
23 Jun 2022
REC opinion
Further Information Favourable Opinion