Safety, Tolerability and PK of PXL770 in Healthy Male Subjects
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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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Actual Study Start Date :
August 21, 2017
Actual Primary Completion Date :
March 16, 2018
Actual Study Completion Date :
March 16, 2018
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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