Overview
Safety, Tolerability and PK of PXL770 in Healthy Male Subjects
Status:
Completed
Completed
Trial end date:
2018-03-16
2018-03-16
Target enrollment:
0
0
Participant gender:
Male
Male
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Poxel SATreatments:
Rosuvastatin Calcium
Criteria
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