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).
●Inclusion Criteria: <Healthy Volunteers only>
<Patients only>
<Healthy Volunteers and Patients>
Total abstinence, in accordance with the lifestyle of the participant, from at least 30 days prior to the first dose until at least 90 days after the last dose.
Ability to understand the study procedures described in the ICF. Willingness and ability to comply with the protocol, and provides written informed consent prior to study participation.
Willingness and ability to swallow study intervention tablets and/or suspension.
Willing to take off dentures or mouth piercing at the time of dosing.
●Exclusion Criteria: <Healthy Volunteers only>
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.
History of rare hereditary galactose and/or Lactose intolerance (eg, congenital lactase deficiency [CLD] or glucose-galactose malabsorption [GGM]).
History or presence of alcoholism within 6 months before the first dosing. Alcohol abuse is defined as 7 or more drinks per week for a woman or 14 or more drinks per week for a man.
History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
Presence of recurring gastrointestinal symptoms (diarrhea, constipation, nausea, heartburn, etc.).
Presence of acute gastrointestinal symptoms within 7 days before the first dosing.
Use of medications for the timeframes and throughout the study (unless specified), with the exception of hormonal contraceptives and medications exempted by the investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study intervention or participant safety (eg, topical drug products without significant systemic absorption).
<Patients only>
Current diagnosis of indeterminate colitis, inflammatory bowel disease-unclassified, Crohn's disease, infectious colitis, or ischaemic colitis.
Evidence of fulminant colitis or ASUC at Screening.
The patient meets the following criteria:
Positive Clostridium difficile toxin test during Screening. However, re-screening can be undertaken following successful treatment.
Complications or history of immunologic, autoimmune or chronic inflammatory disorders (eg, uveitis, rheumatoid arthritis, ankylosing spondylitis or spondyloarthritis, psoriasis) other than UC.
Any evidence of colonic dysplasia, adenomas or polyposis. Those that have been completely resected can be included.
Mentally or legally incapacitated.
A history of malignant neoplasm within the last 5 years, except for adequately treated non-metastatic basal or squamous cell cancers of the skin (within 1 year) or carcinoma in situ of the uterine cervix (within 3 years) that has been fully treated and shows no evidence of recurrence.
History of hypersensitivity or idiosyncratic reaction to the study interventions, excipients (including Lactose) or related compounds, or severe food allergies.
History or presence of alcoholism within 6 months before the first dosing. Alcohol abuse is defined as 7 or more drinks per week for a woman or 14 or more drinks per week for a man.
History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
Previously untreated UC.
Initiation or change in the dose of the following medicines; oral sulfasalazine, aminosalicylate, oral or rectal corticosteroid, ciclosporin, mercaptopurine, azathioprine, methotrexate, anti-TNF biologic, anti-integrin, anti-IL-12/23, anti IL-23 biologics, JAK inhibitor, or S1P1 modulator.
Fecal microbiota transplantation within 4 weeks prior to baseline endoscopy.
Use of medications for the timeframes specified below and throughout the study (unless specified), with the exception of hormonal contraceptives and medications exempted by the investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study intervention or participant safety (eg, topical drug products without significant systemic absorption):
History or evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis diagnosed by a positive QFT-GIT. In case of an indeterminate, borderline, or invalid result, the QFT-GIT may be repeated once or a T-SPOT® TB test may be used to confirm the result. If the results are indeterminate/borderline at repeat testing, the participant should be excluded.
<Healthy Volunteers and Patients>
clinical_trial@ono-pharma.com
Single ascending dose: Participants will receive a single dose of ONO-6414 orally on Day 1.
Multiple ascending dose: Participants will receive ONO-6414 orally for 7 consecutive days.
Single dose: Participants will receive a single dose of ONO-6414 orally on Day 1.
clinical_trial@ono-pharma.com+17162141777(Standard)
A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis
A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis
A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis
A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis
A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis