NCT02547402

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

1 month

First QC Date

September 2, 2015

Last Update Submit

May 2, 2016

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Maximum Plasma Concentration [Cmax]

    14 days

Study Arms (1)

CXA-10

EXPERIMENTAL

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

Drug: CXA-10Drug: pravastatinDrug: Vytorin® (combination of simvastatin and ezetimibe)

Interventions

CXA-10DRUG

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

CXA-10
pravastatinDRUG

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

Also known as: Pravachol®
CXA-10
Vytorin® (combination of simvastatin and ezetimibe)DRUG

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

CXA-10

Eligibility Criteria

Age19 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jasper Clinical Research & Development, Inc.

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

CXA-10PravastatinEzetimibe, Simvastatin Drug CombinationEzetimibe

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsSimvastatinLovastatinAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Thomas Blok, MD

    Jasper Clinic, Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 11, 2015

Study Start

December 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

May 3, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)