PK and PD of Sequential Multiple Ascending, Repeat Doses of Oral CXA-10 in Healthy Obese Male Subjects

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

History of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions, with the exception of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years

History of regular alcohol consumption exceeding 21 units/week (one unit = 125 mL of wine or 284 mL of beer or a single 25 mL measure of spirits) within 6 months of screening

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. Use of any drug including aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) must be avoided within 7 days prior to the first dose and during this study as it may interfere with the pharmacology of CXA-10. Use of high energy supplements or drinks (especially, those containing caffeine, protein supplements, and weight loss drugs)

History of smoking, including e-cigarettes, or use of nicotine-containing products within 1 month of screening

Resting heart rate ≥100 BPM after 5 minutes rest (as above) at the screening visit

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

Any clinically significant murmurs evident on auscultation of the heart (including evidence of mitral valve prolapse)

PK and PD of Sequential Multiple Ascending, Repeat Doses of Oral CXA-10 in Healthy Obese Male Subjects

What this study is about

PK and PD of Sequential Multiple Ascending, Repeat Doses of Oral CXA-10 in Healthy Obese Male Subjects

What this study is about