Clinical trial NCT02547402: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Kidney Injury
Lead sponsor: Complexa, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 10
Sex: MALE
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximum Plasma Concentration [Cmax]
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Jasper Clinical Research & Development, Inc.
state: Michigan
Study officials:
affiliation: Jasper Clinic, Michigan
name: Thomas Blok, MD
role: PRINCIPAL_INVESTIGATOR
References: