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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945539
• Other study ID #: CR108614
• Secondary ID: 2019-000966-3956
• Status: Completed
• Phase: Phase 1
• Start date: May 15, 2019
• Est. completion date: October 4, 2019

Study information

• Verified date: November 2019
• Source: Janssen Sciences Ireland UC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 4, 2019
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit	Merksem

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Sciences Ireland UC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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

External Links

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