A Study to Evaluate the Effect of Itraconazole on JNJ-56136379 in Healthy Adult Participants

An Open-label, Fixed-sequence, Drug-drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of JNJ-56136379 in Healthy Adult Participants

The main purpose of this study is to assess the effect of itraconazole at steady-state on a single-dose pharmacokinetic (PK) of JNJ-56136379 in healthy adult participants.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-56136379; Drug: Itraconazole

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Merksem, Belgium, 2170
    • Clinical Pharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy on the basis of physical examination, clinical laboratory tests, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
• Must not use nicotine-containing substances including tobacco products for at least 3 months prior to screening and during the study
• A woman of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test at Day -1 of the first treatment period
• Body mass index (weight kilogram [kg]/height^2 meter [m]^2) between 18.0 and 30.0 kg/m^2 (inclusive), and body weight not less than 50.0 kg
• Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted

Exclusion Criteria:

• History of cardiac arrhythmias (example [e.g.], tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) at screening
• Any evidence of heart block or bundle branch block at screening
• Any current, or history of, clinically significant skin disease at screening requiring intermittent or chronic treatment (at the investigator's discretion) such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
• Known allergies, hypersensitivity, or intolerance to JNJ-56136379 or itraconazole or its excipients at screening
• History of clinically significant drug allergy at screening such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: JNJ-56136379 and Itraconazole; Participants will receive a single dose of JNJ-56136379 on Day 1 in Treatment Period 1 and itraconazole 200 mg once daily for 21 days starting on Day 34 along with a single dose of JNJ 56136379 on Day 38 in Treatment Period 2. JNJ-56136379 intake in Treatment Period 1 and the first intake of itraconazole in Treatment Period 2 will be separated by a washout period of at least 33 days. Study drug (JNJ-56136379 and itraconazole) intakes will be taken orally and under fed conditions.

Drug: JNJ-56136379; Participants will receive JNJ-56136379 orally on Day 1 in Treatment Period 1 and on Day 38 in Treatment Period 2.; Drug: Itraconazole; Participants will receive 200 mg of itraconazole once daily orally for 21 days starting on Day 34.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Period 1: Area Under the Plasma Analyte Concentration Versus Time Curve From time 0 to 72 hours Postdose (AUC [0-72 hours]) of JNJ-56136379	AUC [0-72 hours] is defined as area under the plasma analyte concentration versus time curve from time 0 to 72 hours postdose.	Predose (Day 1), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours postdose on Day 4
Period 2: Area Under the Plasma Analyte Concentration Versus Time Curve From time 0 to 72 hours Postdose (AUC [0-72 hours]) of JNJ-56136379	AUC [0-72 hours] is defined as area under the plasma analyte concentration versus time curve from time 0 to 72 hours postdose.	Predose (Day 38), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours postdose on Day 41
Period 1: Area Under the Plasma Analyte Concentration Versus Time Curve From Time 0 to 408 Hours Posdose AUC [0-408 hours] of JNJ-56136379	AUC [0-408 hours] is defined as area under the plasma analyte concentration versus time curve from time 0 to 408 hours postdose.	Predose (Day 1), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 408 hours postdose on Day 18
Period 2: Area Under the Plasma Analyte Concentration Versus Time Curve From Time 0 to 408 Hours Posdose AUC [0-408 hours] of JNJ-56136379	AUC [0-408 hours] is defined as area under the plasma analyte concentration versus time curve from time 0 to 408 hours postdose.	Predose (Day 38), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 144, 168, 216, 336 and 408 hours postdose on Day 55
Period 1: Maximum Observed Plasma Analyte Concentration of JNJ-56136379	Cmax is defined as maximum observed plasma analyte concentration.	Predose (Day 1), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 408 hours postdose on Day 18
Period 2: Maximum Observed Plasma Analyte Concentration of JNJ-56136379	Cmax is defined as maximum observed plasma analyte concentration.	Predose (Day 38), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 144, 168, 216, 336 and 408 hours postdose on Day 55

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Event as Measure of Safety and Tolerability	An Adverse Event is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Approximately 100 Days

Collaborators and Investigators

• Sponsor: Janssen Sciences Ireland UC

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): October 4, 2019
• Study Completion (Actual): October 4, 2019

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole; JNJ-56136379
• Other Study ID Numbers: CR108614; 2019-000966-39 (EudraCT Number); 56136379HPB1008 (Other Identifier: Janssen Sciences Ireland UC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No