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Completed

NCT Number: NCT02587416

Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of atorvastatin 80 mg

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Key information

Conditions

Hypercholesteremia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and Females
  • 18-65 years of age
  • Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;
  • Body weight 45 kg or greater, with a body mass index (BMI) ≤ 35 kg/m² (weight [kg]/height[meters]²)

Exclusion criteria

  • If female, of childbearing potential or lactation
  • History of significant adverse reaction to any lipid-lowering agent

Treatment and study plan

Gemcabene 300 mg

Drug

1x300 mg gemcabene tablets orally once daily (QD) for 11 days

Gemcabene 900 mg

Drug

3x300 mg Gemcabene tablets orally once daily (QD) for 11 days

atorvastatin

Drug

2x40 mg Atorvastatin tablets orally once daily (QD)

Primary outcomes

  1. Pharmacokinetics

    Time frame: Days 5, 16 and 27

    Cmax

  2. Pharmacokinetics

    Time frame: Days 5, 16, and 27

    Area Under the Curve (AUC)

Secondary outcomes

  1. Adverse Events

    Time frame: 27 days

  2. Clinical Laboratory - hematology, chemistry, urinalysis

    Time frame: 27 days

    Clinical Laboratory Abnormalities

  3. ECG

    Time frame: 27 days

    Clinically Significant Changes

Sponsors and collaborators

Lead sponsor

NeuroBo Pharmaceuticals Inc.

Industry

Registry information

Official study title

A Study of the Effect of Oral, Multiple-Dose 300 mg and 900 mg Gemcabene (CI-1027) Administration on the Steady-State Pharmacokinetics of Atorvastatin 80 mg

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Oct 27, 2015
Registry last updated
Apr 9, 2020

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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