Expired Study
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Kalamazoo, Michigan 49007


Purpose:

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).


Study 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). 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.


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.


Study is Available At:


Original ID:

CXA-10-203


NCT ID:

NCT02547402


Secondary ID:


Study Acronym:

DDI


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Male


Minimum Age:

19 Years


Maximum Age:

30 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Complexa, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Pharmacokinetics Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Actual


Overall Contact Information

Official Name:Thomas Blok, MD
Principal Investigator
Jasper Clinic, Michigan

Study Dates

Start Date:December 2015
Completion Date:February 2016
Completion Type:Actual
Primary Completion Date:January 2016
Primary Completion Type:Actual
Verification Date:May 2016
Last Changed Date:May 2, 2016
First Received Date:September 2, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Maximum Plasma Concentration [Cmax]
Time Frame:14 days
Safety Issues:False

Study Interventions

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

Study Arms

Study Arm Type:Experimental
Arm Name:CXA-10
Description:CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Complexa, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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