Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

Phase 1

Completed

• Conditions: Hypercholesteremia
• Interventions: Drug: Gemcabene 300 mg; Drug: Gemcabene 900 mg; Drug: Atorvastatin

• Registration Number: NCT02587416
• Lead Sponsor: NeuroBo Pharmaceuticals Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2002-12
• Study Completion: 2002-12
• 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: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Gemcabene 300 mg	Gemcabene 300 mg	Gemcabene 300 mg
Gemcabene 900 mg	Gemcabene 900 mg	Gemcabene 900 mg
Atorvastatin 80 mg	Atorvastatin	Atorvastatin 80 mg
Gemcabene 300 mg	Atorvastatin	Gemcabene 300 mg
Gemcabene 900 mg	Atorvastatin	Gemcabene 900 mg

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	Days 5, 16, and 27	Area Under the Curve (AUC)

Secondary Outcome Measures

Name	Time	Method
Clinical Laboratory - hematology, chemistry, urinalysis	27 days	Clinical Laboratory Abnormalities
Adverse Events	27 days
ECG	27 days	Clinically Significant Changes