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

Sponsor

Complexa, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02547402

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: CXA-10 Drug: pravastatin Drug: Vytorin® (combination of simvastatin and ezetimibe)	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CXA-10 CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid	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. Other Names: Pravachol® Drug: Vytorin® (combination of simvastatin and ezetimibe) It lowers bad cholesterol in the blood, and raises good cholesterol

Arm

Intervention/Treatment

Experimental: CXA-10

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

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.

Other Names:

Pravachol®

Drug: Vytorin® (combination of simvastatin and ezetimibe)

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

Outcome Measures

Primary Outcome Measures

Maximum Plasma Concentration [Cmax] [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.