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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-56136379; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03945539

CR108614

2019-000966-39 (EudraCT Number)

56136379HPB1008 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

JNJ-56136379 and Itraconazole

Experimental group

Description:

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.

Treatment:

Drug: Itraconazole

Drug: JNJ-56136379