None listed
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of JNJ-90858638 compared with placebo after single and multiple ascending dose administration in healthy participants (Part 1 and 2).
Interventions
ARM:
Experimental: Part 1: Single Ascending Dose (SAD) Cohort
Participants will receive a single dose of JNJ-90858638 orally in a fasted or fed state. The high-fat, high-calorie meal will consist of 800-1000 total kilocalorie (kcal) with approximately 500-600 kcal (greater than [>] 50 percent [%]) derived from fat. SAD has 5 planned fasted cohorts, 1 fasted and food effect cohort and 2 optional cohorts; an optional additional food effect cohort, if required. Each participant will participate i
ARM: Experimental: Part 1: Single Ascending Dose (SAD) Cohort Participants will receive a single dose of JNJ-90858638 orally in a fasted or fed state. The high-fat, high-calorie meal will consist of 800-1000 total kilocalorie (kcal) with approximately 500-600 kcal (greater than [>] 50 percent [%]) derived from fat. SAD has 5 planned fasted cohorts, 1 fasted and food effect cohort and 2 optional cohorts; an optional additional food effect cohort, if required. Each participant will participate in 1 cohort only. ASSIGNED INTERVENTION: Drug: JNJ-90858638 JNJ-90858638 will be administered orally. The starting dose for SAD will be 5 milligram (mg); incremental doses are unknown but will be based on PK and safety from preceding cohorts. There is a projected maximum dose of 100 mg. It will be administered by medical professionals including registered nurses. ARM: Experimental: Part 2: Multiple Ascending Dose (MAD) Cohort Participants will receive oral doses of JNJ-90858638 once daily for 28 days in MAD in an ascending fashion in a fasted or fed based (standard meal) state; the dosing regimen will be confirmed based on SAD pharmacokinetic (PK) and safety data. The standard meal will consist of 500-800 kcal with approximately 25-50% of kcal derived from fat. A total of 6 cohorts are planned for Part 2 (4 escalating cohorts [Cohorts 1 to 4] and 2 optional cohorts [Cohorts 5 and 6]). Each participant will participate in 1 cohort only ASSIGNED INTERVENTION: Drug: JNJ-90858638 JNJ-90858638 will be administered orally. The starting dose for MAD will be selected based on PK and safety data from the preceding SAD part. It will be administered by medical professionals including registered nurses.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
- Healthy on the basis of physical examination, medical history, vital signs,12-lead electrocardiogram (ECG) and echocardiography performed at screening and/or Day-1 - Body mass index (BMI) between 18 and 32 kilogram/meter square (kg/m^2), and a body weight of no less than 50 kg - All females must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test on Day -1 and agree to further pregnancy tests - Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion criteria
- History of chronic liver or renal insufficiency significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances - Have an active, acute or chronic infection - Has or has had a serious infection (for example [e.g.], sepsis, pneumonia or pyelonephritis) or has been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 4 months prior to screening - Has or has had an acute illness, including a common cold, within 2 weeks prior to study intervention administration - Has or has had a nontuberculous mycobacterial infection or opportunistic infection (for example, cytomegalovirus, pneumocystosis, and aspergillosis) at any time prior to screening
Outcome results
None listed