Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single- and Multiple-Doses of TAK-020 in Healthy Volunteers

Exclusion Criteria

• •Any participant who meets any of the following criteria will not qualify for entry into the study:
• •1. The participant has received any investigational compound within 30 days prior to Screening.
• •2. The participant is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
• •3. Participant has a known hypersensitivity to any component of the formulation of TAK-020, Captisol or related compounds.
• •4. The participant has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
• •5. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as 4 or more alcoholic beverages per day) within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.
• •6. Participant has taken any excluded medication, supplements, or food products, Prohibited Medications and Dietary Products.
• •7. If female, the participant is pregnant or lactating or intending to become pregnant before, during or within 1 month after exit from this study (30 days post last dose); or intending to donate ova during such time period.
• •8. If male, the participant intends to donate sperm during the course of this study or for 12 weeks thereafter.
• •9. Participant has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-020, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
• •10. Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent \[more than once per week\] occurrence of heartburn, or any surgical intervention \[example, cholecystectomy\]).
• •11. Participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
• •12. Participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1. Cotinine test is positive at Screening or Check-in (Day -1).
• •13. The participant has poor peripheral venous access.
• •14. Participant has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1.
• •15. Vaccination with any live vaccine within 4 weeks of study drug administration.
• •16. Participant has a Screening or Check-in (Day -1) abnormal (clinically significant) ECG. Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator medically qualified sub investigator.
• •17. Participant has QT interval with Fridericia correction method (QTcF) greater than (\>) 450 millisecond (msec) for men and women or PR outside the range of 120 to 220 msec confirmed upon repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1).
• •18. Participant has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities:
• •1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.2\* the upper limit of normal (ULN).
• •2. Positive screen test for drugs of abuse.
• •3. Positive blood screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus-1 or -2 antibodies.
• •4. A positive test for tuberculosis (TB) (QuantiFERON).