Safety, Tolerability and PK of PXL770 in Healthy Male Subjects

Poxel

Status and phase: Completed; Phase 1

Conditions: Metabolic Disease

Treatments: Drug: Placebo; Drug: PXL770; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03395470

PXL770-002

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 6 patient groups

Group A1

Experimental group

Description:

Dose 1 or placebo

Treatment:

Drug: Placebo

Drug: PXL770

Group A2

Experimental group

Description:

Dose 2 or placebo

Treatment:

Drug: Placebo

Drug: PXL770

Group A3

Experimental group

Description:

Dose 3 or placebo

Treatment:

Drug: Placebo

Drug: PXL770

Group A4

Experimental group

Description:

Dose 4 or placebo

Treatment:

Drug: Placebo

Drug: PXL770

Group A5

Experimental group

Description:

Dose 5 or placebo

Treatment:

Drug: Placebo

Drug: PXL770

Group B

Experimental group

Description:

Dose + Rosuvastatin

Treatment:

Drug: Rosuvastatin

Drug: PXL770