Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Adult Male and Female Subjects

Exclusion Criteria

• •1. Pregnant or lactating females or male partners of females who are pregnant or lactating.
• •2. Subjects with any history of clinically significant bronchopulmonary, cardiovascular, cerebrovascular, hematologic, renal, hepatic, neurological, psychiatric, metabolic, or endocrine (eg, diabetes or thyroid disease) disease/disorder.
• •3. Use of prescription or over-the-counter (OTC) drugs, including vitamins and herbal or dietary supplements within 2 weeks (4 weeks for enzyme inducers including St. John's Wort) or 5 half-lives (whichever is longer), prior to the baseline/check-in visit, unless in the opinion of the investigator, prior use of the medication will not interfere with the study procedures or compromise subject safety.
• •4. Subjects with sustained supine or semi-supine systolic blood pressure of \< 90 or \> 140 mm Hg and supine or semi-supine diastolic blood pressure of \< 50 or \> 90 mm Hg at the screening or baseline/check-in visits.
• •5. Subjects with a resting heart rate of \< 45 or \> 100 beats per minute at the screening or baseline/check in visits.
• •6. Subjects with any clinically relevant deviation from normal during the physical examination, including vital signs at the screening or baseline/check-in visits.
• •7. Subjects with a known history of hypercalcemia, hyperparathyroidism, or hypervitaminosis D.
• •8. Use of calcium or vitamin D supplements (prescription or OTC) within 2 weeks prior to the baseline/check-in visit.
• •9. Subjects with a history of allergic reactions or hypersensitivities to galacto-oligosaccharides or any significant drug-related or food-related allergy (such as anaphylaxis or hepatotoxicity).
• •10. Regular use of probiotics, antacids, histamine type 2 (H2)-receptor blockers, proton pump inhibitors, or any medications that may alter the normal gastric environment and/or motility, or use of such medications within 2 weeks prior to the baseline/check-in visit.