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出境医 / 临床实验 / A Study to Evaluate the Effect of Itraconazole on JNJ-56136379 in Healthy Adult Participants

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

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 Intervention/treatment Phase
Healthy Drug: JNJ-56136379 Drug: Itraconazole Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
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 15, 2019
Actual Primary Completion Date : October 4, 2019
Actual Study Completion Date : October 4, 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
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Ages Eligible for Study:   18 Years 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

Locations
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Belgium
Clinical Pharmacology Unit
Merksem, Belgium, 2170
Sponsors and Collaborators
Janssen Sciences Ireland UC
Investigators
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Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC
Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE May 15, 2019
Actual Primary Completion Date October 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of Itraconazole on JNJ-56136379 in Healthy Adult Participants
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: JNJ-56136379
  • Drug: Itraconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2019) 		16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 4, 2019
Actual Primary Completion Date October 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945539
Other Study ID Numbers  ICMJE CR108614
2019-000966-39 ( EudraCT Number )
56136379HPB1008 ( Other Identifier: Janssen Sciences Ireland UC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Janssen Sciences Ireland UC
Study Sponsor  ICMJE Janssen Sciences Ireland UC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC
PRS Account Janssen Sciences Ireland UC
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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