A Study to Evaluate the Safety, Tolerability, and Effects on NSAID-Induced Small Bowel Pathology of K-196 in Healthy Volunteers.
- Conditions
- Inflammatory bowel disease (IBD)10017969
- Registration Number
- NL-OMON51579
- Lead Sponsor
- Kallyope, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
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 <30.0 (kg/m2) at the Screening Visit.
5. Be a nonsmoker who has not used tobacco or nicotine-containing products
(e.g., nicotine patch) for at least 3 months before administration of the
initial dose of trial drug and agrees to abstain from smoking tobacco or the
use of nicotine-containing products while on study.
6. Be judged to be in good health by the Investigator, based on clinical
evaluations including laboratory safety tests, medical history, physical
examination, 12-lead ECG, and vital sign measurements performed at the
Screening Visit and before administration of the initial dose of trial drug.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To characterize the safety and tolerability of multiple oral doses of K-196<br /><br>alone and in combination with naproxen/omeprazole in healthy subjects. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Small bowel mucosal breaks; PK</p><br>