A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: JNJ-64417184; Drug: Famotidine; Drug: Lansoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT04453189

CR108812

64417184RSV1004 (Other Identifier)

2020-000380-23 (EudraCT Number)

Details and patient eligibility

About

The primary purpose of this study is to evaluate the effect of multiple-dose administration of lansoprazole on the single-dose pharmacokinetics (PK) of JNJ-64417184 in healthy adult participants; and to evaluate the effect of time-separated, multiple-dose administration of famotidine on the single-dose PK of JNJ-64417184 in healthy adult participants (optional).

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must have a body mass index (BMI) between 18.0 and 30.0 kilograms per square meters [kg/m^2]), extremes included, and body weight not less than 50.0 kilograms (kg) at screening
• Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening
• Healthy on the basis of clinical laboratory tests performed at screening
• Must have a normal 12-lead Electrocardiogram (ECG) (triplicate) at screening, including: normal sinus rhythm (heart rate between 45 and 100 beats per minute [bpm], extremes included); QT interval corrected for heart rate (QTc) according to Fridericia (QTcF) less than or equal to (<=) 450 milliseconds (ms) for male participants and <= 470 ms for female participants; QRS interval less than (<) 120 ms; PR interval <= 200 ms. If the results of the ECG are outside the normal ranges, the participant may be included only if the investigator judges the deviations from normal ECG 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 sign an informed consent form (ICF) indicating he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities

Exclusion criteria

• History of liver or renal dysfunction (calculated creatinine clearance/estimated glomerular filtration rate (eGFR) <60 milliliter per minute (mL/min) at screening, calculated by the Modification of Diet in Renal Disease [MDRD] formula), 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 clinically significant cardiac arrhythmias (for example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)
• Any evidence of clinically significant 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
• History of hepatitis A, B, or C infection, or current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen), or HCV infection (confirmed by hepatitis C virus [HCV] antibody) at screening

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Treatment Sequence: AB(Part 1) followed by C(Part 2-Optional)

Experimental group

Description:

Participants will received Treatment A (single dose of JNJ-64417184 in fed condition on Day 1) in period 1 followed by Treatment B (lansoprazole on Day 1 to 4 under fasted condition and 2 hours before single dose of JNJ-64417184 in fed condition on Day 5) in period 2 of part 1. There will be a washout period of 7 days between each treatment. Participants will receive Treatment C: optional (famotidine under fasted conditions administered 12 hours before and 12 hours after a single dose of JNJ-64417184 under fed conditions on Day 1) in Part 2, Period 3.

Treatment:

Drug: Lansoprazole

Drug: Famotidine

Drug: JNJ-64417184

Treatment Sequence: BA(Part 1) followed by C(Part 2-Optional)

Experimental group

Description:

Participants will receive Treatment B in period 1 followed by Treatment A in period 2, Part 1. There will be a washout period of 7 days between each treatment. Participants will receive Treatment C: optional (famotidine under fasted conditions administered 12 hours before and 12 hours after a single dose of JNJ-64417184 under fed conditions on Day 1) in Part 2, Period 3.

Treatment:

Drug: Lansoprazole

Drug: Famotidine

Drug: JNJ-64417184