A study to investigate the safety, tolerability, and pharmacokinetics (PK) of ONO-6414 orally in healthy adult participants and in patients with active ulcerative colitis (UC).
Male or female, age ≥18- to ≤55-year-old at the time of signing ICF.
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, 12-lead ECG, vital signs measurements, and laboratory tests results, as evaluated by the investigator.
BMI of 18.0 to 32.0 kg/m2, inclusive, and a body weight of ≥50 kg at Screening.
Male or female, age ≥18-year-old at the time of signing ICF.
Mentally or legally incapacitated.
History or presence of clinically significant medical, surgical or psychiatric condition or disease that in the opinion of the investigator or medical monitor might confound the results of the study or pose an additional risk to the participant by their participation in the study, including but not limited to a history of inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal bleeding; history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection or history or clinical evidence of pancreatic injury or pancreatitis, history of cardiac arrhythmia (both atrial and ventricular). History of uncomplicated appendectomy and uncomplicated cholecystectomy are allowed.
History of any major invasive surgery within 6 months before the first dosing, or minor invasive surgery within 7 days before the first dosing.
History of hypersensitivity or idiosyncratic reaction to the study interventions, excipients (including Lactose) or related compounds, or severe food allergies.
Parallel
ONO-6414
DrugAdministered orally
Placebo
DrugAdministered orally
Safety and tolerability: Number of Participants with Adverse Events (AEs)
All parts
Pharmacokinetic parameter of ONO-6414: Cmax
All parts
Pharmacokinetic parameter of ONO-6414: Tmax
All parts
Pharmacokinetic parameter of ONO-6414: AUC
All parts
Effect of food on Cmax of ONO-6414
SAD part
Effect of food on AUClast of ONO-6414
SAD part
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