Not Yet RecruitingPhase 1ACTRN12626000105347

A Drug-drug Interaction Study of JNJ-90858638 in Healthy Participants (Part 3 and 4: Drug-drug Interaction)

A Phase 1, Single and Multiple Ascending Dose, Drug-drug Interaction, and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-90858638 in Healthy Participants (Part 3 and 4: Drug-drug Interaction)

Sponsor

Janssen Research & Development, LLC

Enrollment

40 participants

Start Date

Jun 18, 2026

Study Type

Interventional

Conditions

Autoimmune Disease

Summary

The purpose of this study is to assess in Part 3 (Itraconazole Drug-drug Interaction [DDI]) the effects of itraconazole on the pharmacokinetic (PK) of JNJ-90858638. Part 4 (Midazolam DDI) will assess the effects of JNJ-90858638 on the plasma PK of midazolam and its metabolite.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria4

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 Criteria5

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

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Interventions

ARM Experimental: Part 3: Itraconazole Drug-drug Interaction (DDI) Cohort Participants in treatment period 1 will receive a single oral dose of JNJ-90858638 followed by treatment period 2 with a s

ARM Experimental: Part 3: Itraconazole Drug-drug Interaction (DDI) Cohort Participants in treatment period 1 will receive a single oral dose of JNJ-90858638 followed by treatment period 2 with a single oral dose of JNJ-90858638 in combination with itraconazole in a fed (standard meal) state. On Day 1, participants will receive a single oral dose of JNJ-90858638. From Day 8 (start of Period 2) through Day 18, participants will receive an oral dose(s) of itraconazole after completion of a standard meal. On Day 11, after a 3-day run-in with itraconazole, participants will also receive a single oral dose of JNJ-90858638 approximately 1 hour after completion of a standard breakfast. The standard meal will consist of 500-800 kcal with approximately 25-50% of kcal derived from fat. Assigned Interventions: Drug: Itraconazole Itraconazole capsules 100 mg will be administered by medical professionals including registered nurses orally. Drug: JNJ-90858638 JNJ-90858638 will be administered orally. The dose for the DDI cohort will be selected based on data from the preceding SAD part (Part 1, ACTRN12625001434482). It will be administered by medical professionals including registered nurses. ARM Experimental: Part 4: Midazolam DDI Cohort Participants will receive JNJ-90858638, midazolam or both orally in a fasted or fed state (the standard meal will consist of 500-800 kcal with approximately 25-50% of kcal derived from fat), in treatment Period 1 and 2. On Day 1 (start of Period 1), all participants will receive oral midazolam under either fasted or fed conditions (decision for participants in Part 4 to be dosed in either a fasted or fed state will be based on the safety, tolerability and preliminary PK information from Part 1 SAD-food effect, ACTRN12625001434482). If fasting, participants will fast overnight for at least 10 hours. If fed, oral midazolam will be administered ~30 minutes after the start of a standardized breakfast. On Day 3 (start of Period 2), Day 10, and Day 17, when JNJ90858638 is co-administered with midazolam, JNJ90858638 will be administered under the same conditions (i.e. either fasted or fed) as Day 1. Assigned Interventions: Drug: Midazolam Midazolam solution (2 mg/ milliliter [mL] or what is available if locally sourced) will be administered by medical professionals including registered nurses orally. Drug: JNJ-90858638 JNJ-90858638 will be administered orally. The dose for the DDI cohort will be selected based on data from the preceding MAD part (Part 2, ACTRN12625001434482). It will be administered by medical professionals including registered nurses