NCT02547402

A Study of the PK Interaction of CXA-10 With Pravastatin and Vytorin® in Healthy Males

An Open-label Exploratory Study of the Pharmacokinetic Interaction of CXA-10 Administered to Steady State With Pravastatin and Vytorin® (Simvastatin and Ezetimibe) in Healthy Males

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Complexa, Inc. · Industry
• Sex: Male
• Age: 19 Years – 30 Years
• Healthy volunteers: Accepted

Summary

This is an exploratory study in a small, well controlled group of healthy subjects to explore the effect of CXA-10 on pravastatin and Vytorin® (combination of simvastatin and ezetimibe).

Detailed description

This is an exploratory study in a small, well controlled group of healthy subjects to explore the effect of CXA-10 on pravastatin and Vytorin® (combination of simvastatin and ezetimibe). The overall design of the trial is to administer drugs that are metabolized through these transporters to quantify the impact CXA-10 may have on the exposure of these drugs. The study will also examine the 24-h urine total creatinine excretion prior to and following administration of CXA-10 to examine the effects of CXA-10, if any, either directly on creatinine transporters or through enhanced creatinine production. To reduce the potential variability in drug exposure levels, the study population will only include male subjects between 19 to 25 years of age.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	CXA-10	CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid
DRUG	pravastatin	It is statin medicine used to lower cholesterol and triglycerides in the blood.
DRUG	Vytorin® (combination of simvastatin and ezetimibe)	It lowers bad cholesterol in the blood, and raises good cholesterol

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-01-01
• Completion: 2016-02-01
• First posted: 2015-09-11
• Last updated: 2016-05-03

Locations

1 site across 1 country: United States