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OpenTrials
Completed

NCT Number: NCT03618316

Effect of Cimetidine on the PK of Imeglimin

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research (HMR)

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI : 18.5-29.9
  • Body weight ≥ 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

Treatment and study plan

Imeglimin

Drug

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

Cimetidine

Drug

400 mg of cimetidine bid from Day 5 to Day 10

Primary outcomes

  1. PK parameters of imeglimin

    Time frame: At Day 1

    Cmax: peak plasma concentration after dosing

Secondary outcomes

  1. PK parameters of imeglimin

    Time frame: From day 1 to day 3

    AUC last:area under the concentration-time curve

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

    Time frame: from day 1 to day 17

    Incidence of Treatment-Emergent Adverse Events

Sponsors and collaborators

Lead sponsor

Poxel SA

Industry

Registry information

Official study title

An Open-label, One-sequence Study to Assess the Effect of Repeated Oral Doses of Cimetidine on the Single Dose Pharmacokinetics, Safety and Tolerability of Imeglimin in Healthy Caucasian Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2018
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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