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

NCT ID: NCT02547402

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-02-29

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CXA-10

CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid

Group Type: EXPERIMENTAL

CXA-10

Intervention Type: DRUG

CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid

pravastatin

Intervention Type: DRUG

It is statin medicine used to lower cholesterol and triglycerides in the blood.

Vytorin® (combination of simvastatin and ezetimibe)

Intervention Type: DRUG

It lowers bad cholesterol in the blood, and raises good cholesterol

Interventions

CXA-10

CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid

Intervention Type: DRUG

pravastatin

It is statin medicine used to lower cholesterol and triglycerides in the blood.

Intervention Type: DRUG

Vytorin® (combination of simvastatin and ezetimibe)

It lowers bad cholesterol in the blood, and raises good cholesterol

Intervention Type: DRUG

Other Intervention Names

Pravachol®

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Complexa, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Blok, MD

Role: PRINCIPAL_INVESTIGATOR

Jasper Clinic, Michigan

Locations

Jasper Clinical Research & Development, Inc.

Kalamazoo, Michigan, United States

Countries

United States

Other Identifiers

CXA-10-203

Identifier Type: -

Identifier Source: org_study_id