Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

NeuroBo Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hypercholesteremia

Treatments: Drug: Atorvastatin; Drug: Gemcabene 900 mg; Drug: Gemcabene 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02587416

A4141002

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Gemcabene 300 mg

Experimental group

Description:

Gemcabene 300 mg

Treatment:

Drug: Atorvastatin

Drug: Gemcabene 300 mg

Gemcabene 900 mg

Experimental group

Description:

Gemcabene 900 mg

Treatment:

Drug: Atorvastatin

Drug: Gemcabene 900 mg

Atorvastatin 80 mg

Active Comparator group

Description:

Atorvastatin 80 mg

Treatment:

Drug: Atorvastatin