Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome

Inclusion Criteria: * Adult males and females between 18 and 60 years of age, inclusive at the time of signing the informed consent document. * Diagnosis of cyclic vomiting syndrome (CVS) using the Rome IV diagnostic criteria. * Otherwise healthy, as determined by the responsible physician, based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit * Negative urine tests for selected drugs of abuse and alcohol breath test at Screening. Exclusion Criteria: * Any significant medical or psychiatric condition that could, in the Investigator's opinion, compromise the subject's safety or interfere with the completion of this protocol. * Any condition, including the presence of laboratory abnormalities or pulmonary condition, which according to the Investigator places the subject at unacceptable risk if he/she were to participate in the study. * A diagnosis of any gastrointestinal disorder other than CVS that in the judgement of the Investigator could compromise the subject's safety or interfere with the interpretation of safety or efficacy data.