TAK-935-OL-DDI-Soticlestat
Research type
Research Study
Full title
A phase 1 open-Label study to Evaluate the Drug-Drug Interaction of Rifampin as a strong CYP3A Inducer on Soticlestat Pharmacokinetics in Healthy Adult Participant.
IRAS ID
306078
Contact name
Devinda Weeraratne
Contact email
Sponsor organisation
Takeda Development Center Americas Inc
Eudract number
2021-004396-14
Duration of Study in the UK
0 years, 0 months, 30 days
Research summary
Summary of Research
A phase 1 open-Label study to Evaluate the Drug-Drug Interaction of Rifampin as a strong CYP3A Inducer( enzyme mainly found in the liver and intestine. It oxidizes small foreign organic molecules like toxins or drugs, so they can remove from the body) on Soticlestat Pharmacokinetics in Healthy Adult Participant. Safety and tolerability will be assessed throughout the study by treatment-emergent adverse events, clinical laboratory evaluations, physical examinations, ECG, vital signs and Columbia-Suicidal Severity Rating Scale.
Soticlestat is a potent and selective cholesterol 24S hydroxylase(a brain-specific cytochrome P450 (CYP) family enzyme, plays a role in the homeostasis of brain cholesterol by converting cholesterol to 24S-hydroxycholesterol) inhibitor currently in development as an oral adjunct to standard of care therapy for treatment of rare paediatric epilepsies referred to as Developmental and Epileptic Encephalopathy( DEE).Soticlestat is a first-in-class therapeautic candidate that has potential to control seizures in treatment-resistant patients with epilepsy by reducing over-activated glutamate signaling modulating reactive astrocytes and reducing over-activated glutamate signaling in neurons.Summary of Results
For the summary of study results in Plain English please see: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba9JjbEJ-2BaH-2FVckYGgOidK10vrBF8EE-2Bpjy4JqZJ6uBC-2FdO0kqVPcpxhbQJdIHIehwTX0USxaUDl7yYS4fvFxq189Q0iON-2Bx-2B47PDa5wHmi7PQ6-2FUqziB049-2Bx1RcNw1gYUIZJKvsOZBBOQ20SytYVE-3DUPpm_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YL14bUq1u7Quy6su1U0nD1wkTEmYWnraFuPFV0JmQHKQSbakpn0-2BSzVpgQxnp79mhOdaV3gawD-2F-2BF1OT3hMay8iD0lSiN7XBDjIixSvudzlvtlYEzX0lvYpRmZLlsf949DQKvvyODyCh-2FTbk-2FSlahxLzChCcxWnewV6txz6PnqKaw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C57ff2451458d4a396c6508db36a7adc9%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638163866023075176%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ugXGqiOkXAJ6PHvEoTiMHb%2FZJNcXoJFKErh78naoO3E%3D&reserved=0
REC name
HSC REC A
REC reference
21/NI/0158
Date of REC Opinion
18 Nov 2021
REC opinion
Further Information Favourable Opinion