Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

• ClinicalTrials.gov Identifier: NCT02373150
• Recruitment Status: Completed
• First Posted: February 26, 2015
• Last Update Posted: February 10, 2017
• Sponsor: Poxel SA
• Information provided by (Responsible Party): Poxel SA

Study Description

Brief Summary:

This study will assess the pharmacokinetics of single and repeated doses of imeglimin in healthy Japanese subjects, and the safety and tolerability of single and repeated doses of imeglimin in healthy Japanese subjects.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: Imeglimin; Drug: Placebo	Phase 1

Detailed Description:

Combined single and repeated dose groups with 3 escalating doses

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Imeglimin in Healthy Japanese Subjects
• Study Start Date: February 2015
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group A1; Dose 1 or placebo	Drug: Imeglimin; Drug: Placebo
Experimental: Group A2; Dose 2 or placebo	Drug: Imeglimin; Drug: Placebo
Experimental: Group A3; Dose 3 or placebo	Drug: Imeglimin; Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. PK parameters of imeglimin after single and repeated doses: - Cmax: peak plasma concentration after dosing, AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite time, - Tmax: time of peak plasma concentration of imeglimin [ Time Frame: From baseline to Day 13 ]
   • Cmax: peak plasma concentration after dosing
   • AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite time
   • AUC0-t: area under the concentration-time curve from 0 to the time of last quantifiable concentration
   • Tmax: time of peak plasma concentration of imeglimin
2. Safety and tolerability of imeglimin: laboratory assessments [ Time Frame: From baseline to Day 13 ]
   • routine hematology, biochemistry, coagulation and urinalysis
   • physical examination
   • 12-lead ECG
   • vital signs
   • capillary glucose
   • incidence of adverse events

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Male or female Japanese 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 18.0-25.0 kg/m2
• 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
• Use of vitamins, herbal medicines, or over-the-counter medication (with the exception of paracetamol [acetaminophen]) within 7 days before first dose of trial medication, or prescribed medication during the 14 days before first dose of trial medication
• 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.

Contacts and Locations

Locations

United Kingdom

Hammersmith Medicines Research (HMR)

London, United Kingdom

Sponsors and Collaborators

Poxel SA

More Information

• Responsible Party: Poxel SA
• ClinicalTrials.gov Identifier: NCT02373150
• Other Study ID Numbers: PXL008-011
• First Posted: February 26, 2015
• Last Update Posted: February 10, 2017
• Last Verified: February 2017

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases