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

Acute Kidney Injury Clinical Trial

— DDI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547402
• Other study ID #: CXA-10-203
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2015
• Last updated: May 2, 2016
• Start date: December 2015
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: Complexa, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 30 Years

Eligibility

Inclusion Criteria:

• In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities for this population and may exceed the limits of the reference ranges, including hematology, clinical chemistry and urinalysis except as noted below.

• Resting HR greater than or equal to 45 beats per minute (BPM) after 5 minute rest at screening.

• QTcF interval must be less than or equal to 430msec at screening and pre-dose.

Exclusion Criteria:

• Any clinically relevant abnormality for this population identified on the screening history, physical or laboratory examinations, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study.

• Any clinical history of cardiovascular events, arrhythmias, fainting, palpitations, personal or family history of congenital prolonged QT syndromes or sudden unexpected death due to a cardiac reason.

• Treatment with any prescription or non-prescription drugs (including vitamins, herbal and dietary supplements) within 7 days or 5 half-lives, whichever is longer, prior to dosing and until collection of the final PK sample.

• History of smoking, including e-cigarettes, or use of nicotine-containing products within 1 month of screening.

• Subjects with any other clinically relevant ECG parameter abnormality (e.g., PR interval, QRS deviation) or any clinically significant ECG abnormality will be excluded from the study.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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

Locations

Country	Name	City	State
United States	Jasper Clinical Research & Development, Inc.	Kalamazoo	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Complexa, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration [Cmax]		14 days	No