Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

• Sponsor: Poxel SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02373150
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 3
• Duration (Months): 8
• Patients Per Site Per Month: 6

Study Details

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
• 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: Feb 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 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 [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 [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

Criteria

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

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

	Site	City	State	Country	Postal Code
1	Hammersmith Medicines Research (HMR)	London		United Kingdom

Sponsors and Collaborators

• Poxel SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poxel SA
• ClinicalTrials.gov Identifier: NCT02373150
• Other Study ID Numbers: PXL008-011
• First Posted: Feb 26, 2015
• Last Update Posted: Feb 10, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 10, 2017