Status:
COMPLETED
Safety, Tolerability and PK of PXL770 in Healthy Male Subjects
Lead Sponsor:
Poxel SA
Conditions:
Metabolic Disease
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03395470
Start Date
August 21 2017
End Date
March 16 2018
Last Update
August 24 2018
Active Locations (1)
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1
Hammersmith Medicines Research (HMR)
London, United Kingdom