A drug interaction study of DS-1971a; ver 1
Research type
Research Study
Full title
A phase 1, open-label, cross-over, fixed-sequence study to evaluate the effect of multiple doses of DS-1971a on the single dose pharmacokinetics of probe substrates for CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP3A4 enzymes in healthy male and female subjects. HMR code (15-002)
IRAS ID
174685
Contact name
Frans Van Den Berg
Contact email
Sponsor organisation
Daiichi Sankyo Development Ltd
Eudract number
2015-000330-30
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
DS-1971a (the study medicine) is an experimental treatment for pain caused by damage to the nerves (neuropathic pain). We hope that the study medicine will work by stopping nerves from sending pain messages to the brain. There are other medicines that do that, but they often don’t work when given alone, so most patients are given a combination. Those medicines also have troublesome side effects, particularly dizziness and drowsiness. We hope that DS-1971a will prevent pain when given alone, without causing troublesome side effects.
Many medicines are broken down in the liver by substances called enzymes. Sometimes, when medicines are taken together, it can affect how quickly the body breaks down the medicines, and how long it takes the body to get rid of them. We’re doing this study to find out if DS-1971a affects 5 liver enzymes (CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP3A4) using existing ‘test’ medicines.
We’ll give 18 healthy men and women, aged 18–65 years, twice-daily doses of 400 mg DS-1971a for 12 days. Before and during DS 1971a repeated dosing, they’ll also take single doses of the test medicines: 2.5 mg midazolam alone and a test medicine cocktail of 20 mg omeprazole, 15 mg pioglitazone, 500 mg tolbutamide and 150 mg bupropion. We’ll compare blood levels of the test medicines with and without DS 1971a, to find out whether DS 1971a affects breakdown of medicines by the liver enzymes.
Participants will take up to 9 weeks to finish the study. They’ll have 2 ward stays (20 nights in total) and 2 outpatient visits.
A pharmaceutical company (Daiichi Sankyo Development Ltd) is funding the study.
The study will take place at 1 centre in London.
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0360
Date of REC Opinion
16 Apr 2015
REC opinion
Favourable Opinion