Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

Phase 1CompletedNCT02587390

NeuroBo Pharmaceuticals Inc.20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Hypercholesterolemia

Interventions

Gemcabene 900 mgDRUG

3x300 mg Gemcabene tablets orally once daily (QD) for 15 days

Simvastatin 80 mgDRUG

2x40 mg Simvastatin tablets orally once daily (QD) for 15 days

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pharmacokinetics

Cmax

Time frame: 15 days

Pharmacokinetics

Area Under the Curve (AUC)

Time frame: 15 days

Secondary Outcomes

Adverse Events

Time frame: 57 days

Clinical Laboratory - hematology, chemistry, urinalysis

Clinical Laboratory Abnormalities

Time frame: 57 days

ECG

Clinically Significant Changes

Time frame: 57 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.