A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, Food Effects, and Drug-drug Interactions of ACP-196 in Healthy Participants

Exclusion Criteria

• - Prior or ongoing clinically significant illness, medical condition, medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator’s opinion, could affect the safety of the subject; alter the absorption, distribution, metabolism, or excretion of the study drug; or impair the assessment of study results.
• - Evidence of ongoing systemic bacterial, fungal, or viral infection (including upper respiratory
• tract infections).
• - Women cannot be pregnant or breast feeding.
• - Significant history of drug or alcohol abuse or addiction within 3 years before study screening or as evidenced by continuing medical complications of prior drug or alcohol use.
• - History of blood or plasma donation within 90 days before first study drug administration.
• - Currently drinking over 21 units/week of ethanol
• - Drug toxicology screen positive for any prohibited drugs, illicit substances, or alcohol.
• - Anticipated need for alcohol, tobacco, or any drug during the study drug administration and immediate follow-up periods.
• - Relative to admission has any of the following exposures: has taken a prescription systemic medication within 14 days; has used an over-the counter systemic medication (other than acetaminophen) within 7 days; has ingested calcium supplements or calcium-containing vitamins within 7 days; has ingested grapefruit, grapefruit juice, or grapefruit-containing products within 7 days; has consumed alcohol within 48 hours; has taken acetaminophen within 24 hours.
• - Positive test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen or hepatitis B core antibody, or hepatitis C antibody.
• - Unwillingness to avoid vigorous physical activity during inpatient clinic confinements.
• - Part 2 only – Inability or unwillingness to eat all of the ingredients of the high-fat, high-calorie meal as specified in the protocol.
• - Part 3 only – Known allergy to itraconazole or other azole compounds.