Clinical trial NCT03139500: A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants
Official title: A Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and an Open-Label Study to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-05-04
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) as a Measure of Safety: Part 1
timeFrame: Approximately up to 12 weeks
measure: Percentage of Participants With AEs as a Measure of Safety: Part 2
timeFrame: Approximately up to 14 weeks
Secondary outcomes:
measure: Plasma Concentration of JNJ-61803534 (Parts 1, 2 and 3)
timeFrame: Pre-dose, up to Day 50 (Part 1), up to Day 60 (Part 2), and up to Day 63 (Part 3)
measure: Plasma Concentration of Midazolam (Part 3)
timeFrame: Pre-dose and up to Day 18
measure: Inhibition of Stimulated IL-17A Production in Diluted Whole Blood (Parts 1 and 2)
timeFrame: Pre-dose, up to Day 22 (Part 1 - SAD) and up to Day 43 (Part 2 - MAD)
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: