Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Gemcabene 50 mg; Drug: Gemcabene 750/600 mg; Drug: Gemcabene 150 mg; Drug: Gemcabene 450 mg; Drug: Gemcabene 900 mg; Drug: Placebo

• Registration Number: NCT02587364
• Lead Sponsor: NeuroBo Pharmaceuticals Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-04
• Primary Completion: 1999-09
• Study Completion: 1999-09
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-27
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcabene 50 mg	Gemcabene 50 mg	Gemcabene 50 mg
Gemcabene 750/600 mg	Gemcabene 750/600 mg	Gemcabene 750/600 mg
Gemcabene 150 mg	Gemcabene 150 mg	Gemcabene 150 mg
Gemcabene 450 mg	Gemcabene 450 mg	Gemcabene 450 mg
Gemcabene 900 mg	Gemcabene 900 mg	Gemcabene 900 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	29 days	Cmax
Pharmacokinetcis	29 days	Area Under the Curve (AUC)

Secondary Outcome Measures

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