A Study of JNJ-68179280 in Healthy Participants

Janssen Research & Development, LLC94 enrolled

Overview

The purpose of this study is to evaluate the safety and tolerability of JNJ-68179280 compared with placebo after administration of single ascending oral doses of JNJ-68179280 administered to healthy participants (Part 1), multiple ascending oral doses of JNJ-68179280, administered to healthy participants once daily (Cohorts 1 through 4) or twice daily (Cohort 5) over 14 consecutive days (Part 2) and multiple ascending oral doses of an alternative JNJ-68179280 formulation, administered to healthy participants once daily over 14 consecutive days (Part 3 if conducted).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

JNJ-68179280DRUG

JNJ-68179280 will be administered as an oral capsule.

PlaceboOTHER

Matching placebo will be administered as an oral capsule.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator * Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel (excluding liver enzymes) including hematology, blood 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 initialed by the investigator * Have the following pre study intervention clinical laboratory values during screening and check-in to the unit (Day -2 or Day -1): a. aspartate transaminase (AST) less than or equal to (\<=) upper limit of normal (ULN), b. alanine aminotransferase (ALT) \<= ULN, c. bilirubin \<= ULN, d. alkaline phosphatase \<= ULN, e. gamma-glutamyl transpeptidase (GGTP) \<= ULN, f. albumin greater than or equal to (\>=) lower limit of normal (LLN) * A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at check-in to the unit on Day -2 or Day -1 * Must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (example: nicotine patch, vaping, hookah) for 3 months prior to screening Exclusion Criteria: * History of liver or renal insufficiency significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * History of malignancy before screening (exceptions are squamous or basal cell carcinomas of the skin and carcinoma in situ of the cervix as long as they are considered cured with minimal risk of recurrence) * Has an active, acute or chronic infection * Has taken any disallowed therapies, concomitant therapy before the planned first dose of study intervention * Has a positive urine drug screen and/or alcohol breath test during screening or on Day 2

Locations (1)

Celerion

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Time frame: Up to 35 days

Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)

SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Time frame: Up to 35 days

Number of Participants with Clinically Significant Abnormalities in Vital Signs

Number of participants with clinically significant abnormalities in vital signs (including temperature \[oral or tympanic\], pulse/heart rate, respiratory rate, and blood pressure) will be reported.

Time frame: Up to 35 days

Number of Participants with Clinically Significant Abnormalities in Physical Examination

Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) will be reported.

Time frame: Up to 35 days

Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests

Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported.

Time frame: Up to 35 days

Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)

Data from ClinicalTrials.gov

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Secondary Outcomes

Part 1, 2 and 3: Plasma Concentration of JNJ-68179280

Plasma concentration of JNJ-68179280 will be reported.

Time frame: Up to 19 days

Part 1, 2 and 3: Urine Concentration of JNJ-68179280

Urine samples will be analyzed to determine the concentration of JNJ-68179280.

Time frame: Up to 19 days

Part 1, 2 and 3: Stool Concentration of JNJ-68179280

Stool samples will be analyzed to determine the concentration of JNJ-68179280.

Time frame: Up to 16 days

Part 1: Plasma Concentration of JNJ-68179280 Under Fasted Condition

Plasma concentration of JNJ-68179280 under fasted condition will be reported.

Time frame: Up to Day 6

Part 1: Plasma Concentration of JNJ-68179280 Under Fed Condition

Plasma concentration of JNJ-68179280 under fed condition will be reported.

Time frame: Up to 13 days

Part 1: Stool Concentration of JNJ-68179280 Under Fasted Condition

Stool samples will be analyzed to determine the concentration of JNJ-68179280 under fasted condition.

Time frame: Up to Day 6

Part 1: Stool Concentration of JNJ-68179280 Under Fed Condition

Stool samples will be analyzed to determine the concentration of JNJ-68179280 under fed conditions.

Time frame: Up to 13 days

Part 1: Number of Participants with TEAEs Under Fasted Condition

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Time frame: Up to 16 days

Part 1: Number of Participants with TEAEs Under Fed Condition

Time frame: Up to 23 days

Part 1: Number of Participants with SAEs Under Fasted Condition

Time frame: Up to 16 days

Part 1: Number of Participants with SAEs Under Fed Condition

Time frame: Up to 23 days

Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fasted Condition

Number of participants with clinically significant abnormalities in vital signs (including temperature \[oral or tympanic\], pulse/heart rate, respiratory rate, and blood pressure) under fasted condition will be reported.

Time frame: Up to 16 days

Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fed Condition

Time frame: Up to 23 days

Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fasted Condition

Time frame: Up to 16 days

Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fed Condition

Time frame: Up to 23 days

Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fasted Condition

Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) under fasted condition will be reported.

Time frame: Up to 16 days

Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fed Condition

Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) under fed condition will be reported.

Time frame: Up to 23 days

Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fasted Condition

Number of participants with clinically significant abnormalities in ECGs under fasted condition will be reported.

Time frame: Up to 16 days

Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fed Condition

Number of participants with clinically significant abnormalities in ECGs under fed condition will be reported.

Time frame: Up to 23 days