A Single-Dose, Open-label, Randomized, Crossover, Multipart, Multicenter Study to Assess the Relative Oral Bioavailability of a JNJ-77242113 Immediate-release Tablet Formulation with Respect to a Solution Formulation and Food Effect of an Immediate-release Tablet Formulation, and to Assess the Relative Oral Bioavailability, Dose Proportionality, and Food Effect of JNJ-77242113 Delayed-release Tablet Formulations in Healthy Participants
- Conditions
- Inflammatory diseasesInflammatory disease
- Registration Number
- NL-OMON52057
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 82
1. Male or female (18 to 60 years, inclusive at screening).
2. Healthy on the basis of physical examination, medical history, and vital
signs, and 12-lead ECG performed at screening and/or before receiving the first
dose of study intervention.
3. Healthy on the basis of clinical laboratory tests performed at screening
and/or before receiving the first dose of study intervention.
4. Body mass index between 18.0 and 30.0 kg/m2, and body weight not less than
50.0 kg at screening.
5. All women must have a negative highly sensitive serum pregnancy test at
screening and must have a negative urine pregnancy test on Day -1 of Treatment
Period 1.
1. History of or current clinically significant medical illness including
cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation
disorders, lipid abnormalities, significant pulmonary disease, including
bronchospastic respiratory disease, diabetes mellitus, hepatic or renal
insufficiency, thyroid disease, neurologic or psychiatric disease,
infection, or any other illness that the investigator considers should exclude
the participant or that could interfere with the interpretation of the study
results.
2. History of malignancy before screening.
3. Criterion modified per Amendment 1:
3.1 Criterion modified per Amendment 2:
3.2 known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its
excipients
known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its
excipients (IB 2021; IB Addendum 2022), or to NaC10.
4. History of GI disease including IBD, toxic megacolon, dysplasia,
gastroesophageal reflux disease, colon cancer, intestinal stenosis, or fistula.
5. History of surgical resection of the stomach, small or large intestine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part 1:<br /><br>- To assess the rate and extent of bioavailability of JNJ-77242113 when<br /><br>administered as immediate-release (IR) tablet formulation relative to an oral<br /><br>solution formulation under fasted conditions, in healthy participants.<br /><br><br /><br>Part 2:<br /><br>- To assess the rate and extent of bioavailability of delayed-release (DR)<br /><br>tablet formulations of JNJ-77242113 containing 2 different amounts of the<br /><br>sodium caprate (NaC10), in healthy participants -Cohort 1.<br /><br>- To assess the rate and extent of bioavailability of JNJ-77242113 when<br /><br>administered as DR tablet formulations relative to an IR tablet formulation, in<br /><br>healthy participants -Cohort 2.<br /><br><br /><br>Part 3:<br /><br>- To assess the rate and extent of bioavailability of JNJ-77242113 when<br /><br>administered as different strengths of DR tablets relative to an IR tablet<br /><br>formulation, in healthy participants - Cohort 3.</p><br>
- Secondary Outcome Measures
Name Time Method