Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of JNJ61803534 in healthy participants after administration of single ascending oral doses of JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14 consecutive days (Part 2) as well as the potential of JNJ-61803534 to interact with other drugs (Part 3).
Interventions
DRUGJNJ-61803534
Participants will receive JNJ-61803534 tablets orally.
DRUGPlacebo
Participants will receive matching placebo.
DRUGMidazolam
Participants will receive single oral dose of midazolam.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) (BMI = weight/height\^2), and a body weight of not less than 50 kilogram (kg) * Participant must be healthy on the basis of their medical history, a physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed during screening * Participant must be healthy on the basis of clinical laboratory tests performed during screening and at Day -1 * A woman must have a negative urine pregnancy test at screening and a negative highly sensitive serum pregnancy test on Day -1
Exclusion criteria
* Participant has a history of liver or renal insufficiency or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, dermatologic, rheumatologic, psychiatric, or metabolic disturbances * Participant has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence * Participant has an active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection * Participant has received an investigational treatment (including investigational vaccines) within 2 months or 5 half-lives (whichever is longer) or used an invasive investigational medical device within 3 months before the planned first dose of study treatment or is currently enrolled in an investigational study * Participant had major surgery, (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of study treatment administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) as a Measure of Safety: Part 1 | Approximately up to 12 weeks | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Percentage of Participants With AEs as a Measure of Safety: Part 2 | Approximately up to 14 weeks | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of JNJ-61803534 (Parts 1, 2 and 3) | Pre-dose, up to Day 50 (Part 1), up to Day 60 (Part 2), and up to Day 63 (Part 3) | Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of of JNJ-61803534. |
| Plasma Concentration of Midazolam (Part 3) | Pre-dose and up to Day 18 | Plasma concentration assessment will be done to characterize the effect of JNJ-61803534 on the PK of midazolam. |
| Inhibition of Stimulated IL-17A Production in Diluted Whole Blood (Parts 1 and 2) | Pre-dose, up to Day 22 (Part 1 - SAD) and up to Day 43 (Part 2 - MAD) | The amount of IL-17A secreted during the ex-vivo stimulation will be measured during the dosing period. |
Countries
Belgium
Outcome results
None listed