A Study to Assess the Relative Oral Bioavailability of a... | NCT02945007

ID	Type	Description	Link
2016-002665-59	EudraCT Number
53718678RSV1007	Other Identifier	Janssen Research & Development, LLC

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JNJ-53718678: PART 1	Experimental	Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and B (novel concept formulation 1), and under fed condition for treatment C (novel concept formulation 1).	Drug: JNJ-53718678
JNJ-53718678: PART 2	Experimental	Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and D (novel concept formulation 2), and under fed condition for treatment E (novel concept formulation 2). Part 2 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.	Drug: JNJ-53718678
JNJ-53718678: PART 3	Experimental	Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and F (novel concept formulation 3), and under fed condition for treatment G (novel concept formulation 3). Part 3 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.	Drug: JNJ-53718678
JNJ-53718678: PART 4	Experimental	Participants will receive a single dose of JNJ-53718678 500 mg under fasted conditions on day 1 for treatment A (solution) and H (novel concept formulation 4), and under fed condition for treatment I (novel concept formulation 4). Part 4 of the study is optional and might be performed depending on the availability of concept formulations and the result of previous part.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JNJ-53718678	Drug	Participants will receive JNJ-53718678 under fed or fasted conditions.	JNJ-53718678: PART 1 JNJ-53718678: PART 2 JNJ-53718678: PART 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678	The Cmax is the maximum observed plasma concentration.	Up to 72 hour of Post-dose
Area Under the Plasma ConcentrationTime Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0last]) of JNJ-53718678	The AUC (0-last) is the area under the plasma concentration time curve from time 0 to the time of the last measurable non-below quantification limit concentration, calculated by liner-linear trapezoidal summation.	Up to 72 hour of Post-dose
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-53718678	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(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.	Up to 72 hour of Post-dose
Relative Bioavailability of JNJ-53718678	The relative bioavailability based on Cmax, AUC(0last), and AUC(0-inf) will be estimated as 100*Test/Reference, where Test is defined as the pharmacokinetic parameters of oral JNJ-53718678 and Reference is defined as currently existing oral solution G024.	Up to 72 hour of Post-dose
Effect of Food on the Bioavailabilty of JNJ-53718678	The effect of food will be evaluated by comparing the pharmacokinetics of JNJ-53718678 under fed conditions with the currently existing oral solution under fasted conditions.	Up to 72 hour of Post-dose

Measure	Description	Time Frame
Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability		Up to 35 days after last study drug intake

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At Screening, a female participant must be of non-childbearing potential as defined in the protocol
Female participants must have a negative serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at Screening
A male participant must be sexually abstinent (defined as refraining from sexual intercourse from Day 1 (day of dosing) until 90 days after study drug intake) or who is sexually active (either heterosexual, including with a pregnant woman, or homosexual) must agree to use a barrier method of contraception (example, condom) from Day 1 (day of dosing) until 90 days after study drug intake
Participant must have a body mass index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter^2 (kg/m2), extremes included
Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic

Exclusion Criteria:

Participant with a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic insufficiency, renal dysfunction (calculated creatinine clearance below 60 milliliter per minute (mL/min) at Screening using the Cockroft-Gault equation), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers that it could interfere with the interpretation of the study results should exclude the participant
Participants with abnormal values for either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (greater than or equal to [>=]1.25 x upper limit of laboratory normal range [ULN])
Participants with lack of good/reasonable venous access
Participants with a past history of heart arrhythmias (extrasystoli, tachycardia at rest) or, history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
Participants with a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) criteria within 5 years before Screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, methadone, benzodiazepines, and hallucinogens) at Screening and on Day -1 of each treatment period