A Phase 1 Study to Evaluate the Effect of the Organic Anion Transporter Inhibitor Probenecid on the Pharmacokinetics of JNJ-64041575 in Healthy Adults

NCT ID: NCT03105986

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-05
• Study Completion Date: 2017-06-16

Brief Summary

The purpose of this study is to evaluate the effect of multiple-dose administration of probenecid on the pharmacokinetics of JNJ-63549109 and JNJ-64167896 after a single dose of JNJ-64041575 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 AB

Participants will receive Treatment A (1000 milligram (mg) oral dose of JNJ-64041575 on Day 1) in Period 1, followed by Treatment B (1000 mg oral dose of JNJ-64041575 on Day 22 along with probenecid 500 mg on Day 21 to Day 28) in Period 2. A washout Period of 21 days will be maintained between each Period.

Group Type: EXPERIMENTAL

JNJ-64041575

Intervention Type: DRUG

Two 500-mg tablets administered as a single oral dose under fasted conditions on Day 1 or Day 22.

Probenecid

Intervention Type: DRUG

One 500-mg tablet administered as a single oral dose with a total of 30 doses (2 doses on Day -1/21 starting in the evening followed by 4 doses per day on the rest of the days).

Treatment sequence BA

Participants will receive Treatment B (1000 mg oral dose of JNJ-64041575 on Day 1 along with probenecid 500 mg on Day -1 to Day 7) in Period 1, followed by Treatment A (1000 mg oral dose of JNJ-64041575 on Day 22) in Period 2. A washout Period of 21 days will be maintained between each Period.

Group Type: EXPERIMENTAL

JNJ-64041575

Intervention Type: DRUG

Two 500-mg tablets administered as a single oral dose under fasted conditions on Day 1 or Day 22.

Probenecid

Intervention Type: DRUG

One 500-mg tablet administered as a single oral dose with a total of 30 doses (2 doses on Day -1/21 starting in the evening followed by 4 doses per day on the rest of the days).

Interventions

JNJ-64041575

Two 500-mg tablets administered as a single oral dose under fasted conditions on Day 1 or Day 22.

Intervention Type: DRUG

Probenecid

One 500-mg tablet administered as a single oral dose with a total of 30 doses (2 doses on Day -1/21 starting in the evening followed by 4 doses per day on the rest of the days).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants must have a body mass index (BMI; weight in [Kilogram] kg divided by the square of height in meters) 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, inclusive, at screening
• Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
• Participant must have a blood pressure (after the participant is supine for 5 minutes) 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 normal [ULN])
• 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 pregnancy test on Day -1 and Day 21

Exclusion Criteria

• Participant has a history of current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease (example: glucose-6-phosphate-dehydrogenase deficiency), coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, 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
• Participants with 1 or more of the following laboratory abnormalities at screening as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table: [1] Serum creatinine grade 1 or greater (>1.0 × [Upper Limit of Normal] ULN) [2] Hemoglobin grade 1 or greater (<=10.5 grams per deciliter [g/dL]) [3] Platelet count grade 1 or greater (<=99,999/ cubic millimeter [mm^3]) [4] Reticulocyte count (absolute) below the lower limit of laboratory normal range [5] Absolute neutrophil count grade 1 or greater (<=1,500/mm^3) [6] Total bilirubin grade 1 or greater (>1.0 × ULN) [7] Any other toxicity grade 2 or above, except for grade 2 elevations of low density lipoprotein cholesterol and/or cholesterol
• Participants with a history of uric acid kidney stones, conditions associated with elevated urinary uric acid excretion, participants with peptic ulcer disease or a history of peptic ulcer disease, or other contra-indications for the use of probenecid
• Participants has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Participants with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs

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

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Charité Research Organisation GmbH

Berlin, , Germany

Countries

Germany

Other Identifiers

64041575RSV1002

Identifier Type: OTHER

Identifier Source: secondary_id

2016-003923-49

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108300

Identifier Type: -

Identifier Source: org_study_id