Healthy
Conditions
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.
Interventions
DRUGJNJ-56136379
Participants will receive JNJ-56136379 orally on Day 1 in Treatment Period 1 and on Day 38 in Treatment Period 2.
DRUGItraconazole
Participants will receive 200 mg of itraconazole once daily orally for 21 days starting on Day 34.
Sponsors
Janssen Sciences Ireland UC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 1: Area Under the Plasma Analyte Concentration Versus Time Curve From time 0 to 72 hours Postdose (AUC [0-72 hours]) of JNJ-56136379 | 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 | 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 2: Maximum Observed Plasma Analyte Concentration of JNJ-56136379 | 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. |
| 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Event as Measure of Safety and Tolerability | 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. |
Countries
Belgium
Outcome results
None listed