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Safety, Tolerability and PK of PXL770 in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395470
Recruitment Status : Completed
First Posted : January 10, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metabolic Disease Drug: PXL770 Drug: Placebo Drug: Rosuvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A1
Dose 1 or placebo
Drug: PXL770
MAD

Drug: Placebo
MAD

Experimental: Group A2
Dose 2 or placebo
Drug: PXL770
MAD

Drug: Placebo
MAD

Experimental: Group A3
Dose 3 or placebo
Drug: PXL770
MAD

Drug: Placebo
MAD

Experimental: Group A4
Dose 4 or placebo
Drug: PXL770
MAD

Drug: Placebo
MAD

Experimental: Group A5
Dose 5 or placebo
Drug: PXL770
MAD

Drug: Placebo
MAD

Experimental: Group B
Dose + Rosuvastatin
Drug: PXL770
MAD

Drug: Rosuvastatin
DDI




Primary Outcome Measures :
  1. Part A: PK parameters of PXL770 after repeated doses Part B: PK parameters of rosuvastatin before and after repeated doses of PXl770 [ Time Frame: From baseline to day 14 ]
    - Cmax: peak plasma concentration after dosing

  2. Part A: PK parameters of PXL770 after repeated doses [ Time Frame: From baseline to day 14 ]
    - AUC0-t: area under the concentration-time curve from 0 extrapolated to time t

  3. Part A: PK parameters of PXL770 after repeated doses [ Time Frame: From baseline to day 14 ]
    - AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: From baseline to day 14 ]
    Incidence of treatment emergent adverse events



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395470


Locations
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United Kingdom
Hammersmith Medicines Research (HMR)
London, United Kingdom
Sponsors and Collaborators
Poxel SA
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Responsible Party: Poxel SA
ClinicalTrials.gov Identifier: NCT03395470    
Other Study ID Numbers: PXL770-002
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors