A Study to Investigate the Safety, Tolerability and Pharm... | NCT03346122

NCT03346122

ID	Type	Description	Link
2017-000229-11	EudraCT Number
64991524EDI1001	Other Identifier	Janssen Research & Development, LLC

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1:JNJ-64991524 Dose Level (DL) 1 or Placebo(SAD Part 1)	Experimental	Participants will receive a single oral dose (Dose level 1) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.	Drug: JNJ-64991524 Dose Level 1 Drug: Placebo
Cohort 2: JNJ-64991524 DL 2 or Placebo (SAD Part 1)	Experimental	Participants will receive a single oral dose (Dose level 2) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.	Drug: JNJ-64991524 Dose Level 2 Drug: Placebo
Cohort 3: JNJ-64991524 DL 3 or Placebo (SAD Part 1)	Experimental	Participants will receive a single oral dose (Dose level 3) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1.	Drug: JNJ-64991524 Dose Level 3 Drug: Placebo
Cohort 4:JNJ-64991524 DL 4 or Placebo (SAD Part 1:Fasted-Fed)	Experimental	Participants will receive a single oral dose (Dose level 4) of either JNJ-64991524 or placebo capsules in a fasted condition on Day 1 and fed condition, on Day 7.	Drug: JNJ-64991524 Dose Level 4 Drug: Placebo
Cohort 5: JNJ-64991524 DL 5 or Placebo (SAD Part 1)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JNJ-64991524 Dose Level 1	Drug	Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.	Cohort 1:JNJ-64991524 Dose Level (DL) 1 or Placebo(SAD Part 1)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Single Ascending Dose (SAD): Number of Participants with Treatment Emergent Adverse Events (AEs) as a Measure of Safety and Tolerability	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent were events between administration of study drug and up to Day 20 that were absent before treatment or that worsened relative to pre-treatment state.	Up to Day 20
Part 2: Multiple Ascending Dose (MAD): Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent were events between administration of study drug and up to Day 28 that were absent before treatment or that worsened relative to pre-treatment state.	Up to Day 28
Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), Cardiac Telemetry and Clinically Significant Laboratory Findings	Number of participants with abnormalities in vital signs, physical examinations, ECG, cardiac telemetry and clinically significant laboratory findings will be measured.	Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)

Secondary Outcomes

Measure	Description	Time Frame
Plasma Concentration of JNJ-64991524	Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of JNJ-64991524.	Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Weigh at least 50 kilogram (kg), and have a body mass index (BMI) of 18 kg/ meter (m)^2 to 30 kg/m^2, inclusive, at screening
Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and Day-1. This determination must be recorded in the participant's source documents and initialed by the investigator
Be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, including liver enzymes, white blood cell count and hematocrit, coagulation, 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 or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and confirmed initialed by the investigator
Have the platelet count pretreatment clinical laboratory values not below the normal range during Screening and Day -1
A woman must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Day -2

Exclusion Criteria:

History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Known allergies, hypersensitivity, or intolerance to JNJ-64991524 or its excipients
History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
Has a history of or is infected with human immunodeficiency virus (HIV [positive serology for HIV antibody]); tests positive for hepatitis B virus (HBV) infection; has antibodies to hepatitis C virus (HCV) at screening