Inflammatory bowel disease (IBD)
Conditions
Interventions
K-196 capsules or matching placebo, naproxen, omeprazole.
Sponsors
Kallyope, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Understand the trial procedures and agree to participate by providing written informed consent. 2. Be willing and able to comply with all trial procedures and restrictions. 3. Be healthy between 18 to 59 years of age, inclusive, at the Screening Visit. 4. Have a Body Mass Index (BMI) >=18.0 and
Exclusion criteria
Exclusion criteria: 1. Has participated in another investigational study within the following time period: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer or based on local regulations) prior to the Screening Visit. The window will be derived from the date of the last study procedure and/or AE related to the study procedure in the previous study to the Screening Visit of the current study. 2. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site. 3. Has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food. 4. Has a known hypersensitivity or contraindication to any component of K-196, related compounds or its excipients. 5. Has known hypersensitivity to naproxen or any components of the drug product 6. Has history of asthma, urticaria or other allergic-type reactions after taking naproxen or other NSAIDs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the safety and tolerability of multiple oral doses of K-196 alone and in combination with naproxen/omeprazole in healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Small bowel mucosal breaks; PK | — |
Countries
Netherlands
Outcome results
None listed