Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Gemcabene 900 mg; Drug: Gemcabene 50 mg; Drug: Gemcabene 150 mg; Drug: Gemcabene 450 mg; Drug: Gemcabene 750/600 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo once daily (QD)
Experimental: Gemcabene 900 mg	Drug: Gemcabene 900 mg; Gemcabene 900 mg once daily (QD)
Experimental: Gemcabene 50 mg	Drug: Gemcabene 50 mg; Gemcabene 50 mg once daily (QD)
Experimental: Gemcabene 150 mg	Drug: Gemcabene 150 mg; Gemcabene 150 mg once daily (QD)
Experimental: Gemcabene 450 mg	Drug: Gemcabene 450 mg; Gemcabene 450 mg once daily (QD)
Experimental: Gemcabene 750/600 mg	Drug: Gemcabene 750/600 mg; Gemcabene 750/600 mg once daily (QD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics	Cmax	29 days
Pharmacokinetcis	Area Under the Curve (AUC)	29 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma lipid levels - percent change from baseline at Day 29	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)	29 days
Adverse Events		29 days
ECG	Clinically Significant Changes	29 days
Clinical Laboratory - hematology, chemistry	Clinical Laboratory Abnormalities	29 days

Collaborators and Investigators

• Sponsor: NeuroBo Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (Actual): September 1, 1999
• Study Completion (Actual): September 1, 1999

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Lipid Regulator
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 1027-003