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Completed

NCT Number: NCT03945539

A Study to Evaluate the Effect of Itraconazole on 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-56136379

Drug

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

Itraconazole

Drug

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

Primary outcomes

  1. 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

    Time frame: Predose (Day 1), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours postdose on Day 4

    AUC [0-72 hours] is defined as area under the plasma analyte concentration versus time curve from time 0 to 72 hours postdose.

  2. 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

    Time frame: Predose (Day 38), 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours postdose on Day 41

    AUC [0-72 hours] is defined as area under the plasma analyte concentration versus time curve from time 0 to 72 hours postdose.

  3. 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

    Time frame: 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

    AUC [0-408 hours] is defined as area under the plasma analyte concentration versus time curve from time 0 to 408 hours postdose.

  4. 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

    Time frame: 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

    AUC [0-408 hours] is defined as area under the plasma analyte concentration versus time curve from time 0 to 408 hours postdose.

  5. Period 1: Maximum Observed Plasma Analyte Concentration of JNJ-56136379

    Time frame: 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

    Cmax is defined as maximum observed plasma analyte concentration.

  6. Period 2: Maximum Observed Plasma Analyte Concentration of JNJ-56136379

    Time frame: 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

    Cmax is defined as maximum observed plasma analyte concentration.

Secondary outcomes

  1. Number of Participants with Adverse Event as Measure of Safety and Tolerability

    Time frame: Approximately 100 Days

    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.

Sponsors and collaborators

Lead sponsor

Janssen Sciences Ireland UC

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 10, 2019
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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