Ulcerative Colitis study: ONO-6414
Official title A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally in Healthy Adult Participants and Patients With Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT07749768
What this study is testing
What is ONO-6414?
This is an investigational medicine being studied as a potential treatment for ulcerative colitis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the drug is safe, how well people tolerate it, and how the body processes it.
- Who it's for
- The study is looking for healthy adults and adults who currently have active ulcerative colitis.
- What's involved
- Participants will take the drug by mouth and undergo tests to check for side effects and measure drug levels in the body.
- Time commitment
- The source text does not specify the total duration or the number of visits required.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
- A diagnosis of ulcerative colitis (UC) must have been established at least three months prior to screening. \
You likely can't join if
- 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...
- 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...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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.
- A diagnosis of ulcerative colitis (UC) must have been established at least three months prior to screening. \
- 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. ●
What rules you out
- 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...
- 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...
- 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...
- 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.
- Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy for UC
- Evidence of abdominal abscess or toxic megacolon during Screening
- Imminent need for surgery or with elective surgery scheduled to occur during the study
- 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...
- 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...
- 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...
- Fecal microbiota transplantation within 4 weeks prior to baseline endoscopy.
- depot injection or implant within 3 months prior to dosing;
- live attenuated vaccines within 1 month prior to dosing;
- MAOIs within 30 days prior to dosing and until 14 days after the last drug administration;
- any drug known to induce or inhibit hepatic drug metabolism, including St. John's Wort, within 30 days prior to dosing;
- prescription medications within 14 days prior to dosing;
- any vaccine, including COVID-19 vaccine, within 14 days prior to dosing;
- OTC medications and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein...
- History or evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis diagnosed by a positive QFT-GIT.
- Use of any investigational drug within 30 days or 5 half-lives of that investigational drug (whichever is longer) before the first dosing.
- Abnormal clinical laboratory test results (and confirmed by a single repeat measurement, if deemed necessary) at Screening or admission.
- Positive result at Screening or admission for the urine or breath alcohol screen, or urine drug screen.
- Clinically significant abnormal laboratory test results or positive serology test results at Screening for HIV-1 Ag with HIV-1 and HIV-2 Ab, HBsAg, HBcAb (even if the result for HBcAb is positive, the negative result...
- Increased CV proarrhythmic potential, confirmed with repeat per investigator discretion, at Screening or admission.
- Clinically significant abnormalities in blood pressure, pulse rate, oral temperature and respiratory rate at Screening or admission.
- Poor venous access as determined by the investigator at Screening.
- The participant smoked (including use of tobacco and/or nicotine containing products including e-cigarettes, snuff, chewing tobacco, cigars, pipes, or nicotine-replacement products) within 3 months before Screening or...
- Female participant who is positive for pregnancy test or lactating or planning to become pregnant during this study or within 3 months after the last study intervention administration.
- Donation of blood ≥500 mL or significant blood loss within 56 days before the first dosing, or blood plasma or platelet donation within 14 days before the first dosing, or blood transfusion within 90 days before the...
- Participant working at or having an immediate family member (spouse or children) who works at the study site or is a staff member of the sponsor and directly involved in this trial.
- Engagement in strenuous exercise (eg, moving large bulky items, bodybuilding) within 14 days before the first dosing.
- Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure.
- Any participant who, in the opinion of the investigator, is not considered to be suitable and is unlikely to comply with the study protocol for any reason.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.