Drug-drug interaction study inhibition potential KL1333
Research type
Research Study
Full title
A Phase I, Open-label, Fixed-sequence, Crossover, Drug-drug Interaction Study to Investigate the Inhibition Potential of KL1333 on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in Healthy Subjects
IRAS ID
287854
Contact name
Hamzah Malik
Contact email
Sponsor organisation
Abliva AB
Eudract number
2020-003727-42
Clinicaltrials.gov Identifier
20/WA/0231, Rec Ref
Duration of Study in the UK
0 years, 1 months, 30 days
Research summary
Mitochondria can be found in most cells and have a role of being the powerhouse of the cell via a complicated series of reactions. They produce energy in the form of adenosine triphosphate (ATP).
Primary mitochondrial diseases are a set of diseases caused by a dysfunction in these chains of reactions which vary in severity and body systems they affect, there are a varying degree of clinical manifestations of the effects of these aberrant reactions.
KL1333 is a new compound to treat this broad spectrum of potentially debilitating and life threatening diseases.This will be a study to investigate the effect of coadministration of KL1333 on the PK (how the drug is used by the body) of repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen in healthy male and female subjects. Subjects will be admitted into the clinical research unit (CRU) on Day -1 and be confined to the CRU until discharge on Day 19. Subjects will return to the CRU for a follow up visit 5 to 7 days after the last dose.
Drug metabolism is a complicated process and a number of enzymes in the liver called CYP enzymes help us metabolise drugs, different enzymes are activated by different drugs, the cocktail selected covers all the enzymes KL1333 is expected to affect from previous laboratory testing, this will enable us to determine how other drugs will interact with KL1333 by observing the PK of these drugs with and without KL1333. 14 Subjects will be selected to take part after the screening process.
They will receive the cocktail of the drugs on two occasions, the first will be between Days 1 and 2, and the second occasion will be between days 13 and 14. From Day 8 to 13 they will also receive KL1333.
REC name
Wales REC 1
REC reference
20/WA/0231
Date of REC Opinion
29 Sep 2020
REC opinion
Further Information Favourable Opinion