Safety, Tolerability and PK of PXL770 in Healthy Male Subjects
- Registration Number
- NCT03395470
- Lead Sponsor
- Poxel SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A1 PXL770 Dose 1 or placebo Group A1 Placebo Dose 1 or placebo Group A2 Placebo Dose 2 or placebo Group A3 Placebo Dose 3 or placebo Group A4 PXL770 Dose 4 or placebo Group A4 Placebo Dose 4 or placebo Group A5 PXL770 Dose 5 or placebo Group A5 Placebo Dose 5 or placebo Group B PXL770 Dose + Rosuvastatin Group B Rosuvastatin Dose + Rosuvastatin Group A2 PXL770 Dose 2 or placebo Group A3 PXL770 Dose 3 or placebo
- Primary Outcome Measures
Name Time Method 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-∞: area under the concentration-time curve from 0 extrapolated to infinite
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] From baseline to day 14 Incidence of treatment emergent adverse events
Trial Locations
- Locations (1)
Hammersmith Medicines Research (HMR)
🇬🇧London, United Kingdom