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

Complexa

Status and phase

Completed

Phase 1

Conditions

Acute Kidney Injury

Treatments

Drug: Vytorin® (combination of simvastatin and ezetimibe)

Drug: pravastatin

Drug: CXA-10

Study type

Interventional

Funder types

Industry

Identifiers

NCT02547402

CXA-10-203

Details and patient eligibility

About

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).

Full 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.

Enrollment

10 patients

Sex

Male

Ages

19 to 30 years old

Volunteers

Accepts 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.