A Crossover Study to Assess the Effect of Intravenous Infusion of Piperacillin/Tazobactam on the Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) in Healthy Adult Participants

NCT ID: NCT03441529

Last Updated: 2018-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-09
• Study Completion Date: 2018-05-03

Brief Summary

The main purpose of this study is to evaluate the effect of intravenous (IV) infusions of piperacillin/tazobactam on the pharmacokinetics (PK) of JNJ-63549109 after a single oral dose of lumicitabine in healthy adult participants.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment Sequence 1 (AB)

Participants will receive Treatment A as a single oral dose of 1000 milligram (mg) lumicitabine (4\*250 mg tablets) on Day 1 of period 1 followed by Treatment B as a single oral dose of 1000 mg lumicitabine (4\*250 mg tablets) together with piperacillin/tazobactam administered as three 30-minute Intravenous (IV) infusions of 4.5 gram (g) piperacillin/tazobactam (4 g of piperacillin and 0.5 g of tazobactam) every 6 hours on Day 1 of period 2. A washout period of at least 21 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

Lumicitabine

Intervention Type: DRUG

Participants will receive single oral dose of 1000 mg lumicitabine as per assigned treatment sequence.

Piperacillin/Tazobactam

Intervention Type: DRUG

Participants will receive three IV infusions of piperacillin/tazobactam combination product (4 g of piperacillin and 0.5 g of tazobactam) every 6 hours on Day 1.

Treatment Sequence 2 (BA)

Participants will receive Treatment B on Day 1 of period 1 followed by Treatment A on Day 1 of period 2. A washout period of at least 21 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

Lumicitabine

Intervention Type: DRUG

Participants will receive single oral dose of 1000 mg lumicitabine as per assigned treatment sequence.

Piperacillin/Tazobactam

Intervention Type: DRUG

Participants will receive three IV infusions of piperacillin/tazobactam combination product (4 g of piperacillin and 0.5 g of tazobactam) every 6 hours on Day 1.

Interventions

Lumicitabine

Participants will receive single oral dose of 1000 mg lumicitabine as per assigned treatment sequence.

Intervention Type: DRUG

Piperacillin/Tazobactam

Participants will receive three IV infusions of piperacillin/tazobactam combination product (4 g of piperacillin and 0.5 g of tazobactam) every 6 hours on Day 1.

Intervention Type: DRUG

Other Intervention Names

JNJ-64041575, ALS-008176

Eligibility Criteria

Inclusion Criteria

• Participant must have a body mass index (BMI); weight in kg divided by the square of height in meters) between 18.0 and 30.0 kilogram per square meter (kg/m^2), extremes included, and a body weight not less than 50.0 kg, inclusive, at screening
• Participant must have a blood pressure between 90 and 140 millimeter of mercury (mmHg) systolic, extremes included, and no higher than 90 mmHg diastolic. If blood pressure is out of range, 1 repeated assessment is permitted after an additional 5 minutes of rest
• Participants must have normal values for alanine transaminase (ALT) and aspartate aminotransferase (AST) (less than or equal to [<=] 1.0*upper limit of laboratory normal range [ULN])
• Participant must have a normal renal function (estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 90 milliliter per minute per 1.73 square meter [mL/min/1.73m^2]) determined by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
• A female Participant, except if postmenopausal, must have a negative serum beta human chorionic gonadotropin (beta hCG) pregnancy test at screening, and a negative urine beta hCG pregnancy test on Day 1 of each treatment period
• Participant must be healthy on the basis of medical history, physical examination, 12 lead electrocardiogram (ECG), vital signs, and laboratory tests performed at screening

Exclusion Criteria

• Participant has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease (example, glucose 6 phosphate dehydrogenase deficiency), coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, seizure disorders, or any other illness, that in the investigator's and/or sponsor's medical monitor opinion should exclude the participant or that could interfere with the interpretation of the study results
• Participant has a history of human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) antibody positive, or tests positive for HIV-1 or -2 at screening
• Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well being) or that could prevent, limit, or confound the protocol specified assessments
• Participants with a history of allergic reactions to any of the penicillins, cephalosporins, monobactams, carbapenems, or beta lactamase inhibitors (clavulanate, sulbactam, tazobactam, avibactam), or other contra indications for the use of piperacillin/tazobactam
• Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides, or drug allergy diagnosed in previous studies with experimental drugs
• Participant has known allergies, hypersensitivity, or intolerance to lumicitabine or its excipients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2017-004504-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64041575RSV1009

Identifier Type: OTHER

Identifier Source: secondary_id

CR108431

Identifier Type: -

Identifier Source: org_study_id