A Study to Investigate the Safety, Tolerability, and Phar... | NCT03151486

NCT03151486

ID	Type	Description	Link
2017-000303-25	EudraCT Number
55308942EDI1001	Other Identifier	Janssen-Cilag International NV

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1:JNJ-55308942 0.5 mg or Placebo (SAD Part)	Experimental	Participants will be randomized to receive a single dose of JNJ-55308942 0.5 milligrams (mg) or matching placebo as an oral solution after an overnight fast on Day 1 of Cohort 1 after single ascending dose (SAD).	Drug: JNJ-55308942 0.5 mg Drug: Placebo
Cohort 2: JNJ-55308942 1.5 mg or Placebo (SAD Part)	Experimental	Participants will be randomized to receive a single dose of JNJ-55308942 1.5 mg or matching placebo as an oral solution after an overnight fast on Day 1.	Drug: JNJ-55308942 1.5 mg Drug: Placebo
Cohort 3: JNJ-55308942 4 mg or Placebo (SAD Part)	Experimental	Participants will be randomized to receive a single dose of JNJ-55308942 4 mg or matching placebo as an oral solution after an overnight fast on Day 1.	Drug: JNJ-55308942 4 mg Drug: Placebo
Cohort 4: (JNJ-55308942 12 mg or Placebo (SAD Part))	Experimental	Participants will be randomized to receive a single dose of JNJ-55308942 12 mg or matching placebo as an oral solution after an overnight fast on Day 1.	Drug: JNJ-55308942 12 mg Drug: Placebo
Cohort 5: JNJ-55308942 36 mg or Placebo (SAD Part)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JNJ-55308942 0.5 mg	Drug	Participants will receive JNJ-55308942 0.5 mg as an oral solution after an overnight fast on Day 1.	Cohort 1:JNJ-55308942 0.5 mg or Placebo (SAD Part)

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.	Up to 6 Weeks
Single Ascending Dose (SAD): Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942	The Cmax is the maximum observed plasma concentration of JNJ-55308942.	Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
SAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942	Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.	Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
SAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-55308942	AUC (0-24h) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to 24 hours postdose.	Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1
SAD: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Observed Quantifiable Concentration (AUC [0-Last]) of JNJ-55308942	AUC (0-last) is defined as area under the plasma JNJ-53308942 concentration-time curve from time 0 to time of the last observed quantifiable concentration.	Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
SAD: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-55308942

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant must have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (BMI = weight [kg] / height [m]^2), and a body weight of not less than 50 kilogram (kg)
Participant must be healthy on the basis of physical examination, neurological examination, medical history, vital signs, and 12 lead (electrocardiogram) ECG, and peripheral capillary oxygen saturation [(SpO2) greater than or equal to (>=) 97 percent] performed at Screening and Day -1
Participant must be healthy on the basis of clinical laboratory tests performed at Screening and Day -1. If the results of the serum chemistry panel, coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
Female participants must not be of childbearing potential by fulfilling 1 of the criteria: a) be over 45 years of age with no menses for 12 months without an alternative medical cause, with screening follicle stimulating hormone (FSH) levels of greater than (>) 40 International Unit per Liter (IU/L) or milli-International Unit per milliliter (mIU/mL). b) be permanently surgically sterile. Permanent surgical sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. Documentation of FSH levels is not required in the case of surgical sterility
Female participants must have a negative serum pregnancy (Beta -human chorionic gonadotropin [Beta -hCG]) test at screening and a negative urine pregnancy test on Day -1

Exclusion Criteria:

Participant has current, or history of, clinically significant medical illness including, but not limited to, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Participant has a history of abnormal bleeding or clotting, or disorder of fibrinogen (example, dysfibrinogenemia, hypofibrinogenemia)
Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence)
Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month or within a period of less than 10 times the drug's half-life, whichever is longer, before the planned first dose of study drug, or is currently enrolled in another investigational study
Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before Screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines, ecstasy, phencyclidine, tricyclic antidepressants, and benzodiazepines) at Screening