Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

NeuroBo Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: Simvastatin 80 mg; Drug: Gemcabene 900 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02587390

1027-008

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Gemcabene 900 mg

Experimental group

Description:

Gemcabene 900 mg

Treatment:

Drug: Gemcabene 900 mg

Drug: Simvastatin 80 mg

Simvastatin 80 mg

Active Comparator group

Description:

Simvastatin 80 mg

Treatment:

Drug: Simvastatin 80 mg