A First-In-Human Study of Orally Administered JNJ-6441718... | NCT03403348

NCT03403348

ID	Type	Description	Link
2017-004363-13	EudraCT Number
JNJ-184-1401	Other Identifier	Janssen Biopharma, Inc.

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1: Single Ascending Dose (SAD)	Experimental	Participants will be enrolled in 7 cohorts and receive one of the 7 corresponding SADs of JNJ-64417184, starting from 40 milligram (mg), or placebo in a fasted state. Dose escalation in the subsequent cohorts will depend on the human maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) in previous cohorts.	Drug: JNJ-64417184 Drug: Placebo
Part 2A: Food Effect	Experimental	Participants enrolled in cohort 4 of part 1 will roll-over in Part 2A and will receive a single oral dose (the same dose as received in Part 1) of JNJ-64417184 or placebo with a high-fat meal.	Drug: JNJ-64417184 Drug: Placebo
Part 2B: Relative Bioavailability (Optional)	Experimental	Participants enrolled in cohorts 5, 6, 7 or any other optional cohorts of Part 1 will roll-over in Part 2B and will receive a single oral dose (the same dose as received in Part 1) of JNJ-64417184 or placebo under fasted state. Dosing may be changed from fasted to a fed state, depending on emerging pharmacokinetics (PK) data from Part 2A.	Drug: JNJ-64417184 Drug: Placebo
Part 3: Multiple Ascending Dose (MAD)	Experimental	Participants will be enrolled in 3 cohorts and will receive one of the 3 corresponding MADs of JNJ-64417184 or placebo, dosed once daily for 7 days. There will be 3 optional cohorts and participants in these cohorts will follow 7- to 14-day dosing schedule. Dosing will either occur in the fasted or the fed state, depending on the outcome of Part 2A. Dose selection and dose escalation in the MAD cohorts will depend on the observed human Cmax and AUC in previous (SAD) cohorts. Additional cohorts may be evaluated at the discretion of the Sponsor and the Principal Investigator (PI).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JNJ-64417184	Drug	Participants will receive JNJ-64417184 in Parts 1, 2A, 2B, 3, 4, 5 and 6.	Part 1: Single Ascending Dose (SAD) Part 2A: Food Effect

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	Approximately up to 8 months
Number of Participants With Laboratory Abnormalities	Number of participants with laboratory abnormalities will be reported.	Approximately up to 8 months
Number of Participants With Clinically Significant Changes in Vital Signs	Number of participants with clinically significant changes in vital signs will be reported.	Approximately up to 8 months
Number of Participants With Clinically Significant Changes in Physical Examination Findings	Number of participants with clinically significant changes in physical examination findings will be reported.	Approximately up to 8 months
Number of Participants With ECG Abnormalities	Number of participants with electrocardiogram (ECG) abnormalities will be reported.	Approximately up to 8 months
Change From Baseline in QT Interval Corrected According to Fridericia's Formula (QTcF) (Parts 1 and 3)	The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG) triplicates.	Baseline up to Day 31
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Absolute as Measured by Spirometry (Part 4)

Secondary Outcomes

Measure	Description	Time Frame
JNJ-64417184 Plasma Concentrations	Plasma concentration of JNJ-64417184 after a single oral dose and after multiple oral doses will be assessed.	Approximately up to 67 days
JNJ-64417184 Urine Concentrations

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant has provided written consent
In the Investigator's opinion, the participant is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned
Participant is in good health as deemed by the Investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG). In case of an out-of-range clinical laboratory test, vital sign, or ECG value that will determine a participant's eligibility, a retest can be done. Results of this retest must be available prior to the first administration of the study drugs (Parts 1, 3, 5, and 6) or prior to inoculation (Part 4). The result of the retest will be considered for participant eligibility
Body mass index (BMI) of 18 to 30 kilogram per meter square (kg/m^2) (inclusive), minimum weight of 50 kilogram (kg)
A female participant is eligible to participate in this study if she is of non childbearing potential defined as either (i) premenopausal with a documented tubal ligation, bilateral oophorectomy, or hysterectomy; or (ii) postmenopausal defined by 12 months of spontaneous amenorrhea and follicle-stimulating hormone level within the laboratory's reference range for postmenopausal females. A postmenopausal female who is receiving hormone replacement therapy and who is willing to discontinue hormone therapy from 28 days before study drug dosing (Parts 1, 3, 5, and 6) or before inoculation (Part 4), and for the entire duration of the study, may be eligible for study participation. A male participant is eligible to participate in this study if (i) he is either surgically sterile or, (ii) in case of having a female partner of childbearing potential, the male participant and partner are practicing and willing to continue to practice highly effective forms of birth control until 90 days after the end of the study. Irrespective of the partner's form of birth control, a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person

Exclusion Criteria:

Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, endocrinologic, oncologic, ophthalmologic, musculoskeletal, psychiatric or any other uncontrolled medical illness
Positive human immunodeficiency virus (HIV), active hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV) test
Creatinine clearance less than (<) 60 milliliter per minute (mL/min) (Cockcroft-Gault)
Drug allergy such as, but not limited to, allergy to penicillins, including allergies experienced in previous studies with experimental drugs
Any condition that, in the opinion of the Investigator, would compromise the study or the well-being of the participant or prevent the participant from meeting the study requirements

Facility	Status	City	State	ZIP	Country	Contacts
hVIVO Services Limited		London		E1 2AX	United Kingdom
Hammersmith Medicines Research Ltd