Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Gemcabene 900 mg; Drug: Simvastatin 80 mg

• Registration Number: NCT02587390
• Lead Sponsor: NeuroBo Pharmaceuticals Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2000-07
• Study Completion: 2000-07
• 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 years of age
• Body weight 45 kg or greater

Exclusion Criteria

• If female, of childbearing potential or lactation
• History of significant adverse reaction to any fibrate lipid-lowering agent or HMG-CoA reductase inhibitor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Gemcabene 900 mg	Simvastatin 80 mg	Gemcabene 900 mg
Simvastatin 80 mg	Simvastatin 80 mg	Simvastatin 80 mg
Gemcabene 900 mg	Gemcabene 900 mg	Gemcabene 900 mg

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	15 days	Area Under the Curve (AUC)

Secondary Outcome Measures

Name	Time	Method
Clinical Laboratory - hematology, chemistry, urinalysis	57 days	Clinical Laboratory Abnormalities
ECG	57 days	Clinically Significant Changes
Adverse Events	57 days