Effect of Cimetidine on the PK of Imeglimin

NCT03618316 | Completed Phase 1

• 1 other identifier: PXL008-023
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to 16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily for 6 days.

Conditions

Healthy

Keywords

pharmacokinetics; Drug-drug interaction

Outcome Measures

Primary Outcomes (1)

• PK parameters of imeglimin

  Cmax: peak plasma concentration after dosing

  At Day 1

Secondary Outcomes (2)

• PK parameters of imeglimin

  From day 1 to day 3

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

  from day 1 to day 17

Study Arms (1)

Open-label imeglimin + cimetidine

EXPERIMENTAL

Day 1: single oral dose of 1,500 mg imeglimin Day 5 to Day 10 inclusive: repeated doses of 400 mg cimetidine twice daily Day 8: second 1,500 mg dose of imeglimin together with the morning dose of cimetidine

Drug: Imeglimin; Drug: Cimetidine

Interventions

Imeglimin DRUG

2 singles oral doses of imeglimin 1,500 mg (one at day 1 and one at day 8)

Open-label imeglimin + cimetidine

Cimetidine DRUG

400 mg of cimetidine bid from Day 5 to Day 10

Open-label imeglimin + cimetidine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Caucasian
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI : 18.5-29.9
• Body weight ≥ 60 kg
• willing to use reliable contraception
• able to give fully informed written consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poxel SA: lead

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, United Kingdom

Location

MeSH Terms

Interventions

imeglimin; Cimetidine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: August 7, 2018
• Study Start: June 19, 2018
• Primary Completion: July 21, 2018
• Study Completion: July 27, 2018
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

GB (1)