Inflammatory diseases Inflammatory disease
Conditions
Interventions
Part 1: Study compound administered to Groups 1 to 6 under different conditions
studying one dose level.
Part 2 and 3: The volunteer will receive the study compound once per period, so
in total 4 t
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: - To assess the rate and extent of bioavailability of JNJ-77242113 when administered as immediate-release (IR) tablet formulation relative to an oral solution formulation under fasted conditions, in healthy participants. Part 2: - To assess the rate and extent of bioavailability of delayed-release (DR) tablet formulations of JNJ-77242113 containing 2 different amounts of the sodium caprate (NaC10), in healthy participants -Cohort 1. - To assess the rate and extent of bioavailability of JNJ-77242113 when administered as DR tablet formulations relative to an IR tablet formulation, in healthy participants -Cohort 2. Part 3: - To assess the rate and extent of bioavailability of JNJ-77242113 when administered as different strengths of DR tablets relative to an IR tablet formulation, in healthy participants - Cohort 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: - To determine the effect of food on the pharmacokinetics (PK) profile of JNJ-77242113, when administered as IR tablet formulation under both fasted and fed conditions, in healthy participants. - To characterize the PK profile of JNJ-77242113 administered as IR tablet formulation under both fasted and fed conditions and as an oral solution formulation under fasted conditions, in healthy participants. - To assess the safety and tolerability of JNJ-77242113 administered as IR tablet formulation under both fasted and fed conditions and as an oral solution formulation under fasted conditions, in healthy participants. Part 2: - To assess dose proportionality when administering different strength JNJ-77242113 DR tablets, in healthy participants -Cohort 1. - To determine the effect of food on the bioavailability and PK of the 10-mg DR tablet formulation of JNJ-77242113, in healthy participants -Cohort 2. - To assess the safety and tolerability of JNJ-77242113 after administration of single oral doses of 4 different DR tablet formulations of JNJ-77242113, in healthy participants. Part 3: - To assess dose proportionality when administering different strength JNJ-77242113 DR tablets, in healthy participants - Cohort 3. - To evaluate the effect of food and the timing of a meal on the bioavailability and PK of the 50-mg DR tablet formulation of JNJ-77242113, in healthy participants - Cohort 4. - To assess the safety and tolerability of JNJ-77242113 after administration of 4 single oral doses, administered as 4 different tablet formulations under fasted conditions (Cohort 3) or administered as 50-mg DR tablet under different food conditions (Cohort 4), in healthy participants. | — |
Countries
Netherlands
Outcome results
None listed