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

NCT03945539 | Completed Phase 1

• 3 other identifiers: CR1086142019-000966-3956136379HPB1008
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Number of Participants with Adverse Event as Measure of Safety and Tolerability

  Approximately 100 Days

Study Arms (1)

JNJ-56136379 and Itraconazole

EXPERIMENTAL

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; Drug: Itraconazole

Interventions

JNJ-56136379 DRUG

Participants will receive JNJ-56136379 orally on Day 1 in Treatment Period 1 and on Day 38 in Treatment Period 2.

JNJ-56136379 and Itraconazole

Itraconazole DRUG

Participants will receive 200 mg of itraconazole once daily orally for 21 days starting on Day 34.

JNJ-56136379 and Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Sciences Ireland UC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

JNJ-56136379; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Janssen Sciences Ireland UC Clinical Trial

  Janssen Sciences Ireland UC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 10, 2019
• Study Start: May 15, 2019
• Primary Completion: October 4, 2019
• Study Completion: October 4, 2019
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)