PXL770 is a direct activator of 5' adenosine monophosphate-activated protein kinase (AMPK) being developed by Poxel S.A. for the treatment of type 2 diabetes mellitus (T2DM). In Part A of this study, we'll test the safety, tolerability and pharmacokinetics (PK) of repeated doses. In Part B, we'll co-administer PXL770 and rosuvastatin (a HMG-CoA reductase inhibitor) to assess any drug-drug interaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Hammersmith Medicines Research (HMR)
London, United Kingdom
Part A: PK parameters of PXL770 after repeated doses Part B: PK parameters of rosuvastatin before and after repeated doses of PXl770
\- Cmax: peak plasma concentration after dosing
Time frame: From baseline to day 14
Part A: PK parameters of PXL770 after repeated doses
\- AUC0-t: area under the concentration-time curve from 0 extrapolated to time t
Time frame: From baseline to day 14
Part A: PK parameters of PXL770 after repeated doses
\- AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite
Time frame: From baseline to day 14
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of treatment emergent adverse events
Time frame: From baseline to day 14
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