Clinical trial NCT02945007: A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-53718678 Administered as Oral Concept Formulation Compared to the Current Oral Solution and to Assess the Effect of Food on the Pharmacokinetics of Oral Concept Formulation
Official title: A Phase 1, Open-label, Randomized Crossover Study, in Healthy Adult Subjects to Assess the Relative Oral Bioavailability of a Single 500-mg Dose of JNJ-53718678 Administered as (an) Oral Concept Formulation(s) Compared to the Current Oral Solution and to Assess the Effect of Food on the Pharmacokinetics of (an) Oral Concept Formulation(s)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-10-26
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the relative bioavailability of 1 to 3 concept formulations of JNJ-53718678 compared to the currently existing oral solution, and to assess the effect of food on the bioavailability of 1 to 3 oral concept formulations of JNJ-53718678 when administered as a single oral dose of 500 milligram (mg) in healthy adult participants.


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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678
timeFrame: Up to 72 hour of Post-dose
measure: Area Under the Plasma ConcentrationTime Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0last]) of JNJ-53718678
timeFrame: Up to 72 hour of Post-dose
measure: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-53718678
timeFrame: Up to 72 hour of Post-dose
measure: Relative Bioavailability of JNJ-53718678
timeFrame: Up to 72 hour of Post-dose
measure: Effect of Food on the Bioavailabilty of JNJ-53718678
timeFrame: Up to 72 hour of Post-dose
Secondary outcomes:
measure: Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability
timeFrame: Up to 35 days after last study drug intake
Other outcomes:
Locations:
city: Merksem
country: Belgium
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: