Metabolic Disease
Conditions
Brief summary
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.
Interventions
Sponsors
Poxel SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male subjects deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine * body mass index in the range 18.5-29.9 kg/m² * body weight at least 60 kg * willing to use reliable contraception * able to give fully informed written consent.
Exclusion criteria
* Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception * Clinically relevant abnormal findings at the screening assessment * Clinically significant vital signs outside the acceptable range at screening * Clinically relevant abnormal medical history, surgery or concurrent medical condition * Acute or chronic illness * Estimated glomerular filtration rate less than 80 mL/min/1.73 m2 * Severe adverse reaction to any drug or sensitivity to the trial medication or its components * Significant food allergy; vegetarian or vegan * Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication * Drug or alcohol abuse * Smoking of more than 5 cigarettes daily * Possibility that subject will not cooperate * Positive test for hepatitis B & C, HIV * Objection by a General Practitioner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: PK parameters of PXL770 after repeated doses Part B: PK parameters of rosuvastatin before and after repeated doses of PXl770 | From baseline to day 14 | \- Cmax: peak plasma concentration after dosing |
| Part A: PK parameters of PXL770 after repeated doses | From baseline to day 14 | \- AUC0-t: area under the concentration-time curve from 0 extrapolated to time t |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | From baseline to day 14 | Incidence of treatment emergent adverse events |
Countries
United Kingdom
Outcome results
None listed