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Completed

NCT Number: NCT02587364

Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.

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Key information

Conditions

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

Age range

18 year–55 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

  • Good health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and laboratory assessments
  • Body weight: 60-100 kg (desirable)

Exclusion criteria

  • Use of any medication not considered acceptable by the clinical investigators during the 14-day period before the start of the study (Day 1) ;
  • Donation of a unit of blood or participation in a study of investigational or marketed drugs during the 30-day period before the start of the study (Day 1);
  • If female, of childbearing potential or lactating;
  • History of significant reaction to any fibrate lipid-lowering agent; and
  • Significant urine collection of any drug which could interfere with the study

Treatment and study plan

Gemcabene 50 mg

Drug

Gemcabene 50 mg once daily (QD)

Gemcabene 150 mg

Drug

Gemcabene 150 mg once daily (QD)

Gemcabene 450 mg

Drug

Gemcabene 450 mg once daily (QD)

Gemcabene 750/600 mg

Drug

Gemcabene 750/600 mg once daily (QD)

Gemcabene 900 mg

Drug

Gemcabene 900 mg once daily (QD)

Placebo

Drug

Placebo once daily (QD)

Primary outcomes

  1. Pharmacokinetics

    Time frame: 29 days

    Cmax

  2. Pharmacokinetcis

    Time frame: 29 days

    Area Under the Curve (AUC)

Secondary outcomes

  1. Plasma lipid levels - percent change from baseline at Day 29

    Time frame: 29 days

    percent change from baseline for LDL-C, apolipoprotein B (apoB), total cholesterol (TC), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)

  2. Adverse Events

    Time frame: 29 days

  3. ECG

    Time frame: 29 days

    Clinically Significant Changes

  4. Clinical Laboratory - hematology, chemistry

    Time frame: 29 days

    Clinical Laboratory Abnormalities

Sponsors and collaborators

Lead sponsor

NeuroBo Pharmaceuticals Inc.

Industry

Registry information

Official study title

An Oral, Rising, Multiple-Dose Tolerance, Pharmacokinetic and Pharmacodynamic Study of Gemcabene Capsules in Healthy Volunteers

Important dates

Study start
1999
Primary completion
1999
Study completion
1999
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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