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

  • Clinicaltrials.gov identifier

    NCT03945539

  • Recruitment Status

    Completed

  • First Posted

    May 10, 2019

  • Last update posted

    November 27, 2019

Study Description

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.

  • Condition or Disease:Healthy
  • Intervention/Treatment: Drug: JNJ-56136379
    Drug: Itraconazole
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 16 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official 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
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: October 2019
  • Actual Study Completion Date: October 2019

Arms and interventions

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.

Outcome Measures

  • Primary Outcome Measures: 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 Outcome Measures: 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.

Eligibility Criteria

  • Ages Eligible for Study: 18 to 55 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Locations

Belgium
Clinical Pharmacology Unit
Merksem

Sponsors and Collaborators

Janssen Sciences Ireland UC

Investigators

Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC

More Information

  • Responsible Party: Janssen Sciences Ireland UC
  • ClinicalTrials.gov Identifier: NCT03945539 History of Changes
  • Other Study ID Numbers: CR108614, 2019-000966-39, 56136379HPB1008
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: November 27, 2019
  • Last Verified: November 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • 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
  • URL: https://www.janssen.com/clinical-trials/transparency
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No