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Subjects were excluded if they had clinically significant concomitant diseases or disorders, clinically significant abnormal values in clinical laboratory screening tests, any history of gastrointestinal surgery, had used any prescription or non-prescription drugs within 3 weeks prior to dosing of trial product (except hormone replacement therapy, contraceptives and occasional use of paracetamol in the food-effect trial), were smokers (dosing conditions trial) or were not able or willing to refrain from smoking while staying at the clinic (food-effect trial), or if they were pregnant or breastfeeding women (food-effect trial)
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Common cardiovascular effects include tachycardia, palpitations, and elevated blood pressure
The structured dose-escalation protocol used in the trial was specifically designed to mitigate gastrointestinal burden, and this approach is likely to inform any future prescribing guidance
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