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

Primary Purpose

Acute Kidney Injury

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CXA-10

pravastatin

Vytorin® (combination of simvastatin and ezetimibe)

About this trial

This is an interventional treatment trial for Acute Kidney Injury

Eligibility Criteria

19 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Jasper Clinical Research & Development, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CXA-10

Arm Description

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

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration [Cmax]

Secondary Outcome Measures

Full Information

NCT ID

NCT02547402

First Posted

September 2, 2015

Last Updated

May 2, 2016

Sponsor

Complexa, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02547402

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Complexa, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CXA-10

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CXA-10

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

pravastatin

Other Intervention Name(s)

Pravachol®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Vytorin® (combination of simvastatin and ezetimibe)

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Plasma Concentration [Cmax]

Time Frame

14 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Blok, MD

Organizational Affiliation

Jasper Clinic, Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jasper Clinical Research & Development, Inc.

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49007

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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