Effects of multiple doses of Lu AF35700 on the PK of CYP Substrates
Research type
Research Study
Full title
Interventional, open-label, multiple-dose, single-center study to assess the effects of multiple doses of Lu AF35700 on the pharmacokinetics of cytochrome P450 (CYP450) substrates dextromethorphan (CYP2D6), caffeine (CYP1A2), omeprazole (CYP2C19), and midazolam (CYP3A4) in healthy young adults
IRAS ID
220444
Contact name
Firas Almazedi
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2016-003187-39
Clinicaltrials.gov Identifier
17/EE/0083, REC number
Duration of Study in the UK
0 years, 5 months, 14 days
Research summary
Lu AF35700 (Study Drug) is being developed as a potential treatment for schizophrenia. Schizophrenia is a severe and disabling psychiatric disorder characterised by disturbances in thinking, perception and emotion. Schizophrenia is a treatable condition; however, not all treatments are effective for all patients. It is hoped that the Study Drug will provide effective treatment for these patients without the troublesome side effects.
So far, 83 healthy subjects and 96 patients have received this drug and these studies have shown that Lu AF35700 is safe and well tolerated. In developing new medicines it is vital that we understand how the Study Drug will interact with other drugs; drug interactions can lead to severe side effects. This is a drug interaction study. We will be assessing how Lu AF35700 affects how the body handles a drug called midazolam and a ‘drug cocktail’ which will include midazolam, caffeine, omeprazole and dextromethorphan.
Up to 26 participants are planned to take part in this single site research study. An equal number of men and women will be enrolled. Volunteers will check in on Day -1 and check out on Day 35. They will receive the following drugs throughout their stay:
Day 1: Single 4mg oral dose of midazolam
Day 2: Subjects will receive a single dose of the ‘drug cocktail’ (Caffeine tablets 200mg, Omeprazole 40mg, Dextromethorphan 30mg and IV Midazolam 0.025mg/kg)
Day 5 to 26: Single 10mg oral dose of Lu AF35700
Day 27: Single 4mg oral dose of midazolam and single 10mg oral dose of Lu AF35700
Day 28: Single 10mg oral dose of Lu AF35700 and ‘drug cocktail’ (Caffeine tablets 200mg, Omeprazole 40mg, Dextromethorphan 30mg and IV Midazolam 0.025mg/kg).
Following this, they will have a further 5 outpatient visits. The total duration of the study from screening until follow up is expected to be around 13 weeks.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0083
Date of REC Opinion
25 May 2017
REC opinion
Further Information Favourable Opinion