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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Complexa, Inc.
• Treatments: CXA-10; Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Pravastatin; Simvastatin

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.