A drug interaction study of MT-8554 v1
Research type
Research Study
Full title
An open-label, drug-drug interaction study to investigate the effects of MT-8554 on the pharmacokinetics of simvastatin and rosuvastatin in healthy male Caucasian subjects (15–018).
IRAS ID
192593
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Mitsubishi Tanabe Pharma Europe Ltd.
Eudract number
2015-002912-33
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
MT-8554 (the study medicine) is an experimental medicine for treating pain caused by damage to the nerves (neuropathic pain).
Many patients with neuropathic pain also take widely prescribed, cholesterol-lowering medicines called statins, such as rosuvastatin or simvastatin. Sometimes, when rosuvastatin or simvastatin are taken with another medicine, the body takes longer to get rid of them. We’re doing this study to assess the effect of repeated doses of the study medicine on the blood levels of rosuvastatin and simvastatin, and how quickly the body gets rid of those medicines. We’ll also assess whether the study medicine has any important side effects when taken with rosuvastatin and simvastatin.
We’ll give 28 healthy men, aged 18–55 years, 7 doses of the study medicine and 2 single doses of rosuvastatin and simvastatin. Participants will take one dose of rosuvastatin and simvastatin alone and one dose of each medicine together with the study medicine.
Participants will take up to 6 weeks to finish the study. They’ll have one study session, in which they’ll stay on the ward for 13 nights in a row. They’ll make 2 outpatient visits, for screening and a final check-up.
A pharmaceutical company (Mitsubishi Tanabe Pharma Corporation) is funding the study.
The study will take place at 1 centre in London. We’ll recruit healthy participants by: advertising; word of mouth; volunteer databases; and via our websites.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1903
Date of REC Opinion
17 Dec 2015
REC opinion
Favourable Opinion