HealthyPhase 1NCT03468777

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

A Phase 1 study testing Lumicitabine, Lansoprazole and Ranitidine in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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)… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Lumicitabine, Lansoprazole and Ranitidine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteBelgium
Study dates: 6 Mar 2018to 9 Jul 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Clinical Pharmacology Unit
Merksem, 2170

Other trials in Belgium

About this study

Official title: A Phase 1, Open-label, Randomized, 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 Subjects

Conditions: Healthy
Being tested: Lumicitabine, Lansoprazole, Ranitidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LumicitabineDrug
Also called JNJ-64041575, ALS-008176
Participants will receive single oral dose of 1000 mg lumicitabine as per assigned treatment sequence.
LansoprazoleDrug
Participants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence.
RanitidineDrug
Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.

Study groups in NCT03468777
Study group	Role	What they receive
Part 1: Treatment Sequence (ABC)	Experimental	Participants will receive Treatment A as a single oral dose of 1000 milligram (mg) lumicitabine (4250 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 (4250 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. Receives: Drug: Lumicitabine; Drug: Lansoprazole; Drug: Ranitidine
Part 1: Treatment Sequence (BAC)	Experimental	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. Receives: Drug: Lumicitabine; Drug: Lansoprazole; Drug: Ranitidine
Optional Part 3: Treatment Sequence (DEF)	Experimental	Participants will receive Treatment D as a single oral dose of 1000 mg lumicitabine (4250 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 (4250 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. Receives: Drug: Lumicitabine; Drug: Lansoprazole; Drug: Ranitidine
Optional Part 3: Treatment Sequence (EFD)	Experimental	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. Receives: Drug: Lumicitabine; Drug: Lansoprazole; Drug: Ranitidine
Optional Part 3: Treatment Sequence (FDE)	Experimental	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. Receives: Drug: Lumicitabine; Drug: Lansoprazole; Drug: Ranitidine
Optional Part 3: Treatment Sequence (FED)	Experimental	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. Receives: Drug: Lumicitabine; Drug: Ranitidine
Optional Part 3: Treatment Sequence (EDF)	Experimental	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. Receives: Drug: Lumicitabine; Drug: Lansoprazole; Drug: Ranitidine
Optional Part 3: Treatment Sequence (DFE)	Experimental	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. Receives: Drug: Lumicitabine; Drug: Lansoprazole; Drug: Ranitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

Observed Plasma Concentration at 12 Hours Post dose (C12h) of JNJ-63549109 (Metabolite of JNJ- 64041575)
C12h is observed plasma concentration at 12 hours post dose.
Measured: 12 hours postdose (Day 1)
Observed Plasma Concentration at 24 Hours Post dose (C24h) of JNJ-63549109 (Metabolite of JNJ- 64041575)
C24h is observed plasma concentration at 24 hours post dose.
Measured: 24 hours postdose (Day 2)
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of JNJ- 64041575)
Cmax is the maximum observed plasma concentration.
Measured: Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-63549109 (Metabolite of JNJ-64041575)
Tmax is the actual sampling time to reach maximum observed plasma concentration.
Measured: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Area Under Plasma Concentration Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of JNJ-63549109 (Metabolite of JNJ-64041575)
Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non BQL]) concentration, calculated by linear trapezoidal summation.
Measured: Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-63549109 (Metabolite of JNJ-64041575)
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/ lambda(z); wherein AUC (0- last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Measured: Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Elimination Half-Life (T1/2) of JNJ-63549109 (Metabolite of JNJ-64041575)
T1/2 is the apparent terminal elimination half-life, calculated as 0.693/Lambda(z).
Measured: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Elimination Rate Constant (Lambda[z]) of JNJ-63549109 (Metabolite of JNJ-64041575)
Lambda[z] is the apparent terminal elimination rate constant, estimated by linear regression using the terminal logarithmic (log)-linear phase of the log-transformed concentration vs time data.
Measured: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)

Secondary outcomes (9)

Observed Plasma Concentration at 12 Hours Post dose (C12h) of JNJ-64167896 (Metabolite of JNJ- 64041575)
C12h is observed plasma concentration at 12 hours post dose.
Measured: 12 hours postdose (Day 1)
Observed Plasma Concentration at 24 Hours Post dose (C24h) of JNJ-64167896 (Metabolite of JNJ- 64041575)
C24h is observed plasma concentration at 24 hours post dose.
Measured: 24 hours postdose (Day 2)
Maximum Observed Plasma Concentration (Cmax) of JNJ-64167896 (Metabolite of JNJ-64041575)
Cmax is the maximum observed plasma concentration.
Measured: Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-64167896 (Metabolite of JNJ-64041575)
Tmax is the actual sampling time to reach maximum observed plasma concentration.
Measured: Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Area Under Plasma Concentration Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of JNJ-64167896 (Metabolite of JNJ-64041575)
Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non BQL]) concentration, calculated by linear trapezoidal summation.
Measured: Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-64167896 (Metabolite of JNJ-64041575)
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Measured: Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Elimination Half-Life (T1/2) of JNJ-64167896 (Metabolite of JNJ-64041575)
T1/2 is the apparent terminal elimination half-life, calculated as 0.693/Lambda(z).
Measured: Predose, 15 min, 30 min,1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Elimination Rate Constant (Lambda[z]) of JNJ 64167896 (Metabolite of JNJ-64041575)
Lambda[z] is the apparent terminal elimination rate constant, estimated by linear regression using the terminal logarithmic (log)-linear phase of the log-transformed concentration vs time data.
Measured: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment.
Measured: Up to end of study (approximately 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 20189 Jul 2018

First posted19 Mar 2018
Study start6 Mar 2018
Primary completion9 Jul 2018
Study completion9 Jul 2018

Why it stopped: The study has been terminated due to pending data analysis

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03468777
Sponsor's protocol ID: CR108437
Other IDs: 2017-004832-12, 64041575RSV1010, 2017
Status last verified: Jul 2018
First submitted: 12 Mar 2018
Last updated: 23 Jul 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Randomized, 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 Subjects
ClinicalTrials.gov ID: NCT03468777
Acronym / sponsor ID: CR108437
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study has been terminated due to pending data analysis
Enrolment: 18 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 6 Mar 2018 (actual)
Primary completion: 9 Jul 2018 (actual)
Study completion: 9 Jul 2018 (actual)
First posted: 19 Mar 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Part 1: Treatment Sequence (ABC)	Experimental	Drug: Lumicitabine, Drug: Lansoprazole, Drug: RanitidineParticipants will receive Treatment A as a single oral dose of 1000 milligram (mg) lumicitabine (4250 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 (4250 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.
Part 1: Treatment Sequence (BAC)	Experimental	Drug: Lumicitabine, Drug: Lansoprazole, Drug: RanitidineParticipants 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.
Optional Part 3: Treatment Sequence (DEF)	Experimental	Drug: Lumicitabine, Drug: Lansoprazole, Drug: RanitidineParticipants will receive Treatment D as a single oral dose of 1000 mg lumicitabine (4250 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 (4250 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.
Optional Part 3: Treatment Sequence (EFD)	Experimental	Drug: Lumicitabine, Drug: Lansoprazole, Drug: RanitidineParticipants 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.
Optional Part 3: Treatment Sequence (FDE)	Experimental	Drug: Lumicitabine, Drug: Lansoprazole, Drug: RanitidineParticipants 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.
Optional Part 3: Treatment Sequence (FED)	Experimental	Drug: Lumicitabine, Drug: RanitidineParticipants 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.
Optional Part 3: Treatment Sequence (EDF)	Experimental	Drug: Lumicitabine, Drug: Lansoprazole, Drug: RanitidineParticipants 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.
Optional Part 3: Treatment Sequence (DFE)	Experimental	Drug: Lumicitabine, Drug: Lansoprazole, Drug: RanitidineParticipants 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LumicitabineAlso: JNJ-64041575, ALS-008176Participants will receive single oral dose of 1000 mg lumicitabine as per assigned treatment sequence.	Drug	Optional Part 3: Treatment Sequence (DEF), Optional Part 3: Treatment Sequence (DFE), Optional Part 3: Treatment Sequence (EDF), Optional Part 3: Treatment Sequence (EFD), Optional Part 3: Treatment Sequence (FDE), Optional Part 3: Treatment Sequence (FED), Part 1: Treatment Sequence (ABC), Part 1: Treatment Sequence (BAC)
LansoprazoleParticipants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence.	Drug	Optional Part 3: Treatment Sequence (DEF), Optional Part 3: Treatment Sequence (DFE), Optional Part 3: Treatment Sequence (EDF), Optional Part 3: Treatment Sequence (EFD), Optional Part 3: Treatment Sequence (FDE), Part 1: Treatment Sequence (ABC), Part 1: Treatment Sequence (BAC)
RanitidineParticipants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.	Drug	Optional Part 3: Treatment Sequence (DEF), Optional Part 3: Treatment Sequence (DFE), Optional Part 3: Treatment Sequence (EDF), Optional Part 3: Treatment Sequence (EFD), Optional Part 3: Treatment Sequence (FDE), Optional Part 3: Treatment Sequence (FED), Part 1: Treatment Sequence (ABC), Part 1: Treatment Sequence (BAC)

Primary outcome

Observed Plasma Concentration at 12 Hours Post dose (C12h) of JNJ-63549109 (Metabolite of JNJ- 64041575)
Time frame: 12 hours postdose (Day 1)
C12h is observed plasma concentration at 12 hours post dose.
Observed Plasma Concentration at 24 Hours Post dose (C24h) of JNJ-63549109 (Metabolite of JNJ- 64041575)
Time frame: 24 hours postdose (Day 2)
C24h is observed plasma concentration at 24 hours post dose.
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of JNJ- 64041575)
Time frame: Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Cmax is the maximum observed plasma concentration.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-63549109 (Metabolite of JNJ-64041575)
Time frame: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Tmax is the actual sampling time to reach maximum observed plasma concentration.
Area Under Plasma Concentration Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of JNJ-63549109 (Metabolite of JNJ-64041575)
Time frame: Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non BQL]) concentration, calculated by linear trapezoidal summation.
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-63549109 (Metabolite of JNJ-64041575)
Time frame: Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/ lambda(z); wherein AUC (0- last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Elimination Half-Life (T1/2) of JNJ-63549109 (Metabolite of JNJ-64041575)
Time frame: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
T1/2 is the apparent terminal elimination half-life, calculated as 0.693/Lambda(z).
Elimination Rate Constant (Lambda[z]) of JNJ-63549109 (Metabolite of JNJ-64041575)
Time frame: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Lambda[z] is the apparent terminal elimination rate constant, estimated by linear regression using the terminal logarithmic (log)-linear phase of the log-transformed concentration vs time data.

9 secondary outcomes

Observed Plasma Concentration at 12 Hours Post dose (C12h) of JNJ-64167896 (Metabolite of JNJ- 64041575)
Time frame: 12 hours postdose (Day 1)
Observed Plasma Concentration at 24 Hours Post dose (C24h) of JNJ-64167896 (Metabolite of JNJ- 64041575)
Time frame: 24 hours postdose (Day 2)
Maximum Observed Plasma Concentration (Cmax) of JNJ-64167896 (Metabolite of JNJ-64041575)
Time frame: Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-64167896 (Metabolite of JNJ-64041575)
Time frame: Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Area Under Plasma Concentration Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of JNJ-64167896 (Metabolite of JNJ-64041575)
Time frame: Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-64167896 (Metabolite of JNJ-64041575)
Time frame: Predose, 15 min, 30 min, 1h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Elimination Half-Life (T1/2) of JNJ-64167896 (Metabolite of JNJ-64041575)
Time frame: Predose, 15 min, 30 min,1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Elimination Rate Constant (Lambda[z]) of JNJ 64167896 (Metabolite of JNJ-64041575)
Time frame: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 hours and end of study (16 days after last study drug intake or early withdrawal) (approximately 2 to 3 months)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to end of study (approximately 6 months)

Results and safety

The study was stopped early (reason given: The study has been terminated due to pending data analysis). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lumicitabine, Lansoprazole and Ranitidine in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study has been terminated due to pending data analysis). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observed Plasma Concentration at 12 Hours Post dose (C12h) of JNJ-63549109 (Metabolite of JNJ- 64041575) (time frame: 12 hours postdose (Day 1)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03468777.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.