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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03139500
• Other study ID #: CR108320
• Secondary ID: 2016-004085-2661
• Status: Terminated
• Phase: Phase 1
• Start date: May 17, 2017
• Est. completion date: April 5, 2018

Study information

• Verified date: July 2018
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: April 5, 2018
• Est. primary completion date: April 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-61803534
Participants will receive JNJ-61803534 tablets orally.
• Placebo
Participants will receive matching placebo.
• Midazolam
Participants will receive single oral dose of midazolam.

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit	Merksem

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs) as a Measure of Safety: Part 1	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.	Approximately up to 12 weeks
Primary	Percentage of Participants With AEs as a Measure of Safety: Part 2	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.	Approximately up to 14 weeks
Secondary	Plasma Concentration of JNJ-61803534 (Parts 1, 2 and 3)	Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of of JNJ-61803534.	Pre-dose, up to Day 50 (Part 1), up to Day 60 (Part 2), and up to Day 63 (Part 3)
Secondary	Plasma Concentration of Midazolam (Part 3)	Plasma concentration assessment will be done to characterize the effect of JNJ-61803534 on the PK of midazolam.	Pre-dose and up to Day 18
Secondary	Inhibition of Stimulated IL-17A Production in Diluted Whole Blood (Parts 1 and 2)	The amount of IL-17A secreted during the ex-vivo stimulation will be measured during the dosing period.	Pre-dose, up to Day 22 (Part 1 - SAD) and up to Day 43 (Part 2 - MAD)