PXL770: safety, blood levels, effects & interaction with rosuvastatin
Research type
Research Study
Full title
A double-blind, randomised, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of PXL770, including an open-label, one-sequence part to assess the drug-drug interaction with rosuvastatin in healthy male subjects (HMR code: 17-006)
IRAS ID
230922
Contact name
Denisa Wilkes
Contact email
Sponsor organisation
Poxel SA
Eudract number
2017-002303-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The study medicine is an experimental treatment for type 2 diabetes. People with diabetes can’t process the sugary and starchy foods in their diet quickly enough, and so have high blood sugar. If diabetes isn’t treated, patients are at risk of developing heart disease and diseases of the blood vessels. We hope that the study medicine will improve the sugar and fat levels in patients with diabetes.\n\nThe study will have 2 parts. In Part A, we’ll give healthy men single and repeated doses of the study medicine. We aim to find out the side effects, blood levels and effects of giving repeated doses of this medicine. In Part B, we’ll give healthy men a single dose of rosuvastatin (a medicine given to some diabetic patients to help control cholesterol and other fatty substances), before and after daily doses of the study medicine. We aim to find out if the study medicine affects blood levels of rosuvastatin and if taking both medicines together is well tolerated.\n\nWe’ll start Part A with a small daily dose of the study medicine, and increase the dose as the study progresses. The results from Part A will help us decide how long and how often we should give the study medicine in Part B. \n\nUp to 64 healthy men, aged 18–55 years, will be recruited in Part A, some of whom might be healthy and overweight. 12 healthy men, aged 18–55 years, will be recruited in Part B.\n\nEach participant will take up to 7 weeks to finish the study; they’ll make up to 6 outpatient visits, and stay on the ward for up to 17 nights. \n\nA pharmaceutical company (Poxel SA) is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
17/NI/0123
Date of REC Opinion
1 Aug 2017
REC opinion
Further Information Favourable Opinion