Safety, Tolerability and PK of PXL770 in Healthy Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-21

Study Completion Date

2018-03-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Metabolic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A1

Dose 1 or placebo

Group Type EXPERIMENTAL

PXL770

Intervention Type DRUG

MAD

Placebo

Intervention Type DRUG

MAD

Group A2

Dose 2 or placebo

Group Type EXPERIMENTAL

PXL770

Intervention Type DRUG

MAD

Placebo

Intervention Type DRUG

MAD

Group A3

Dose 3 or placebo

Group Type EXPERIMENTAL

PXL770

Intervention Type DRUG

MAD

Placebo

Intervention Type DRUG

MAD

Group A4

Dose 4 or placebo

Group Type EXPERIMENTAL

PXL770

Intervention Type DRUG

MAD

Placebo

Intervention Type DRUG

MAD

Group A5

Dose 5 or placebo

Group Type EXPERIMENTAL

PXL770

Intervention Type DRUG

MAD

Placebo

Intervention Type DRUG

MAD

Group B

Dose + Rosuvastatin

Group Type EXPERIMENTAL

PXL770

Intervention Type DRUG

MAD

Rosuvastatin

Intervention Type DRUG

DDI

Interventions

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PXL770

MAD

Intervention Type DRUG

Placebo

MAD

Intervention Type DRUG

Rosuvastatin

DDI

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes