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Safety, Tolerability and PK of PXL770 in Healthy Male Subjects

Primary Purpose

Metabolic Disease

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

PXL770

Placebo

Rosuvastatin

About this trial

This is an interventional treatment trial for Metabolic Disease

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts 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

Sites / Locations

Hammersmith Medicines Research (HMR)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Group A1

Group A2

Group A3

Group A4

Group A5

Group B

Arm Description

Dose 1 or placebo

Dose 2 or placebo

Dose 3 or placebo

Dose 4 or placebo

Dose 5 or placebo

Dose + Rosuvastatin

Outcomes

Primary Outcome Measures

Part A: PK parameters of PXL770 after repeated doses Part B: PK parameters of rosuvastatin before and after repeated doses of PXl770

- Cmax: peak plasma concentration after dosing

Part A: PK parameters of PXL770 after repeated doses

- AUC0-t: area under the concentration-time curve from 0 extrapolated to time t

Part A: PK parameters of PXL770 after repeated doses

- AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Incidence of treatment emergent adverse events

Full Information

NCT ID

NCT03395470

First Posted

November 6, 2017

Last Updated

August 23, 2018

Sponsor

Poxel SA

1. Study Identification

Unique Protocol Identification Number

NCT03395470

Brief Title

Safety, Tolerability and PK of PXL770 in Healthy Male Subjects

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

August 21, 2017 (Actual)

Primary Completion Date

March 16, 2018 (Actual)

Study Completion Date

March 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poxel SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A1

Arm Type

Experimental

Arm Description

Dose 1 or placebo

Arm Title

Group A2

Arm Type

Experimental

Arm Description

Dose 2 or placebo

Arm Title

Group A3

Arm Type

Experimental

Arm Description

Dose 3 or placebo

Arm Title

Group A4

Arm Type

Experimental

Arm Description

Dose 4 or placebo

Arm Title

Group A5

Arm Type

Experimental

Arm Description

Dose 5 or placebo

Arm Title

Group B

Arm Type

Experimental

Arm Description

Dose + Rosuvastatin

Intervention Type

Drug

Intervention Name(s)

PXL770

Intervention Description

MAD

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

MAD

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Intervention Description

DDI

Primary Outcome Measure Information:

Title

Part A: PK parameters of PXL770 after repeated doses Part B: PK parameters of rosuvastatin before and after repeated doses of PXl770

Description

- Cmax: peak plasma concentration after dosing

Time Frame

From baseline to day 14

Title

Part A: PK parameters of PXL770 after repeated doses

Description

- AUC0-t: area under the concentration-time curve from 0 extrapolated to time t

Time Frame

From baseline to day 14

Title

Part A: PK parameters of PXL770 after repeated doses

Description

- AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite

Time Frame

From baseline to day 14

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

Incidence of treatment emergent adverse events

Time Frame

From baseline to day 14

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Hammersmith Medicines Research (HMR)

City

London

Country

United Kingdom

12. IPD Sharing Statement

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Safety, Tolerability and PK of PXL770 in Healthy Male Subjects

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