A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Participants

NCT ID: NCT03468777

Last Updated: 2018-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-06
• Study Completion Date: 2018-07-09

Brief Summary

The main purpose of study is to evaluate the effect of multiple-dose administration of lansoprazole (and optional: time-separated single dose administration of ranitidine) on the pharmacokinetics (PK) of JNJ-63549109 after a single dose of lumicitabine in healthy adult participants, under fasted (and optional: fed) conditions.

Conditions

Healthy

Study Design

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

Study Groups

Part 1: Treatment Sequence (ABC)

Participants will receive Treatment A as a single oral dose of 1000 milligram (mg) lumicitabine (4\*250 mg tablets) under fasted condition on Day 1 of period 1 then Treatment B as a single oral dose of 30 mg lansoprazole under fasted condition on Days 1 to 4 and on Day 5 (administered 2 hours before a single oral dose of 1,000 mg lumicitabine) in period 2 followed by Treatment C (optional Part 2) as a single dose of 150 mg ranitidine administered after 2 hours of single dose of 1000 mg lumicitabine (4\*250 mg tablets) under fasted condition on Day 1 of period 3. 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.

Lansoprazole

Intervention Type: DRUG

Participants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence.

Ranitidine

Intervention Type: DRUG

Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.

Part 1: Treatment Sequence (BAC)

Participants will receive Treatment B on Days 1 to 5 of period 1 then Treatment A on Day 1 of period 2 followed by Treatment C (optional Part 2) on Day 1 of period 3. 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.

Lansoprazole

Intervention Type: DRUG

Participants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence.

Ranitidine

Intervention Type: DRUG

Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.

Optional Part 3: Treatment Sequence (DEF)

Participants will receive Treatment D as a single oral dose of 1000 mg lumicitabine (4\*250 mg tablets) after standardized breakfast on Day 1 of period 1 then Treatment E as a single oral dose of 30 mg lansoprazole under fasted condition on Days 1 to 4 and on Day 5 (administered 2 hours before a single oral dose of 1,000 mg lumicitabine) in period 2 followed by Treatment F as a single oral dose of 150 mg ranitidine administered after 2 hours after a single oral dose of 1000 mg lumicitabine (4\*250 mg tablets) after standardized breakfast on Day 1 of period 3. 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.

Lansoprazole

Intervention Type: DRUG

Participants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence.

Ranitidine

Intervention Type: DRUG

Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.

Optional Part 3: Treatment Sequence (EFD)

Participants will receive Treatment E on Days 1 to 5 of period 1 then Treatment F on Day 1 of period 2 followed by Treatment D on Day 1 of period 3. 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.

Lansoprazole

Intervention Type: DRUG

Participants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence.

Ranitidine

Intervention Type: DRUG

Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.

Optional Part 3: Treatment Sequence (FDE)

Participants will receive Treatment F on Days 1 of period 1 then Treatment D on Day 1 of period 2 followed by Treatment E on Days 1 to 5 of period 3. 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.

Lansoprazole

Intervention Type: DRUG

Participants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence.

Ranitidine

Intervention Type: DRUG

Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.

Optional Part 3: Treatment Sequence (FED)

Participants will receive Treatment F on Day 1 of period 1 then Treatment E on Days 1 to 5 of period 2 followed by Treatment D on Days 1 of period 3. 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.

Ranitidine

Intervention Type: DRUG

Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.

Optional Part 3: Treatment Sequence (EDF)

Participants will receive Treatment E on Days 1 to 5 of period 1 then Treatment D on Day 1 of period 2 followed by Treatment F on Day 1 of period 3. 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.

Lansoprazole

Intervention Type: DRUG

Participants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence.

Ranitidine

Intervention Type: DRUG

Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.

Optional Part 3: Treatment Sequence (DFE)

Participants will receive Treatment D on Day 1 period 1 then Treatment F on Day 1 of period 2 followed by Treatment E on Days 1 to 5 of period 3. 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.

Lansoprazole

Intervention Type: DRUG

Participants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence.

Ranitidine

Intervention Type: DRUG

Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.

Interventions

Lumicitabine

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

Intervention Type: DRUG

Lansoprazole

Participants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence.

Intervention Type: DRUG

Ranitidine

Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.

Intervention Type: DRUG

Other Intervention Names

JNJ-64041575, ALS-008176

Eligibility Criteria

Inclusion Criteria

• Participant must be healthy on the basis of medical history, physical examination, 12 lead electrocardiogram (ECG), vital signs, and laboratory tests performed at screening
• 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 meter per square (mL/min/1.73m^2) determined by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)

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 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, proton pump inhibitors (PPIs), H2 blockers or their excipients
• Participants with evidence of any active infection, or participants with presence of any febrile illness or symptoms of upper or lower respiratory tract infection in the 14 days before the (first) administration of study drugs

• 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

2017-004832-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64041575RSV1010

Identifier Type: OTHER

Identifier Source: secondary_id

CR108437

Identifier Type: -

Identifier Source: org_study_id