Clinical Research Directory

Inclusion Criteria: * Is able to provide voluntary, written informed consent. * Continuous nonsmoker who has not used nicotine- or tobacco-containing products for at least 3 months prior to the first dosing. Exclusion Criteria: * Is mentally or legally incapacitated or has significant emotional problems at the time of the Screening visit or expected during the conduct of the study. * History or presence of clinically significant medical or psychiatric condition or disease, including depression, bipolar disease, or psychosis, in the opinion of the PI or designee. * Has acute or chronic liver disease or a history of moderate hepatic impairment (Child-Pugh Class B) or severe hepatic impairment (Child-Pugh Class C). Additional inclusion/exclusion criteria may apply, per protocol.