Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Hypercholesteremia
• Intervention / Treatment: Drug: Gemcabene 300 mg; Drug: Atorvastatin; Drug: Gemcabene 900 mg

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gemcabene 900 mg	Drug: Atorvastatin; 2x40 mg Atorvastatin tablets orally once daily (QD); Drug: Gemcabene 900 mg; 3x300 mg Gemcabene tablets orally once daily (QD) for 11 days
Experimental: Gemcabene 300 mg	Drug: Gemcabene 300 mg; 1x300 mg gemcabene tablets orally once daily (QD) for 11 days; Drug: Atorvastatin; 2x40 mg Atorvastatin tablets orally once daily (QD)
Active Comparator: Atorvastatin 80 mg	Drug: Atorvastatin; 2x40 mg Atorvastatin tablets orally once daily (QD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics	Cmax	Days 5, 16 and 27
Pharmacokinetics	Area Under the Curve (AUC)	Days 5, 16, and 27

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events		27 days
Clinical Laboratory - hematology, chemistry, urinalysis	Clinical Laboratory Abnormalities	27 days
ECG	Clinically Significant Changes	27 days

Collaborators and Investigators

• Sponsor: NeuroBo Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): December 1, 2002
• Study Completion (Actual): December 1, 2002

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; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: A4141002