A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-64417184

Study type: Interventional

Funder types: Industry

Identifiers

NCT04258189

64417184RSV1007 (Other Identifier)

CR108752

2019-004189-16 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess the food effect on the single-dose pharmacokinetic (PK) of the JNJ-64417184 oral solution, administered as 2 different formulations, in healthy adult participants.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must have a body mass index (BMI; weight [kg]/height^2 [m^2]) between 18.0 and 30.0 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg at screening
• Healthy on the basis of physical examination, medical and surgical 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
• Healthy on the basis of clinical laboratory tests performed at screening
• Must have a normal 12-lead electrocardiogram (ECG) (triplicate) at screening
• Female participant must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta- hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1

Exclusion criteria

• History of liver or renal dysfunction significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
• Past history of cardiac arrhythmias (example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
• Any evidence of heart block or bundle branch block at screening
• Current human immunodeficiency virus type-1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
• A history of clinically significant drug allergy 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: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 10 patient groups

Panel 1: Treatment Sequence ABDC

Experimental group

Description:

Participants will receive Treatment A (a single dose of JNJ-64417184 \[oral solution with preservatives\] in fasted condition) in treatment Period 1; followed by Treatment B (a single dose of JNJ-64417184 \[oral solution with preservatives\] in fed \[high-fat meal\] condition) in treatment Period 2; followed by Treatment D (a single dose of JNJ-64417184 \[oral solution without preservatives\] in fed \[high-fat meal\] condition) in treatment Period 3, followed by Treatment C (a single dose of JNJ-64417184 \[oral solution without preservatives\] in fasted condition) in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Treatment:

Drug: JNJ-64417184

Panel 1: Treatment Sequence BCAD

Experimental group

Description:

Participants will receive Treatment B in treatment Period 1; followed by Treatment C in treatment Period 2; followed by Treatment A in treatment Period 3, followed by Treatment D in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Treatment:

Drug: JNJ-64417184

Panel 1: Treatment Sequence CDBA

Experimental group

Description:

Participants will receive Treatment C in treatment Period 1; followed by Treatment D in treatment Period 2; followed by Treatment B in treatment Period 3, followed by Treatment A in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Treatment:

Drug: JNJ-64417184

Panel 1: Treatment Sequence DACB

Experimental group

Description:

Participants will receive Treatment D in treatment Period 1; followed by Treatment A in treatment Period 2; followed by Treatment C in treatment Period 3, followed by Treatment B in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Treatment:

Drug: JNJ-64417184

Optional Panel 2: Treatment Sequence EFG

Experimental group

Description:

Participants will receive Treatment E (a single dose of JNJ-64417184 \[oral solution with or without preservatives\] in fasted condition) in treatment Period 1; followed by Treatment F (a single dose of JNJ-64417184 \[oral solution with or without preservatives\] in fed \[high-fat meal\] condition) in treatment Period 2; followed by Treatment G (a single dose of JNJ-64417184 \[oral solution with or without preservatives\] in fed \[high-fat meal\] condition) in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Treatment:

Drug: JNJ-64417184

Optional Panel 2: Treatment Sequence FGE

Experimental group

Description:

Participants will receive Treatment F in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment E in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Treatment:

Drug: JNJ-64417184

Optional Panel 2: Treatment Sequence GEF

Experimental group

Description:

Participants will receive Treatment G in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment F in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Treatment:

Drug: JNJ-64417184

Optional Panel 2: Treatment Sequence GFE

Experimental group

Description:

Participants will receive Treatment G in treatment Period 1; followed by Treatment F in treatment Period 2; followed by Treatment E in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Treatment:

Drug: JNJ-64417184

Optional Panel 2: Treatment Sequence EGF

Experimental group

Description:

Participants will receive Treatment E in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment F in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Treatment:

Drug: JNJ-64417184

Optional Panel 2: Treatment Sequence FEG

Experimental group

Description:

Participants will receive Treatment F in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment G in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Treatment:

Drug: JNJ-64417184