Clinical trial NCT04844463: A Study of JNJ-68179280 in Healthy Participants
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-68179280 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-04-14
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 35 days
measure: Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: Up to 35 days
measure: Number of Participants with Clinically Significant Abnormalities in Vital Signs
timeFrame: Up to 35 days
measure: Number of Participants with Clinically Significant Abnormalities in Physical Examination
timeFrame: Up to 35 days
measure: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests
timeFrame: Up to 35 days
measure: Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)
timeFrame: Up to 28 days
Secondary outcomes:
measure: Part 1, 2 and 3: Plasma Concentration of JNJ-68179280
timeFrame: Up to 19 days
measure: Part 1, 2 and 3: Urine Concentration of JNJ-68179280
timeFrame: Up to 19 days
measure: Part 1, 2 and 3: Stool Concentration of JNJ-68179280
timeFrame: Up to 16 days
measure: Part 1: Plasma Concentration of JNJ-68179280 Under Fasted Condition
timeFrame: Up to Day 6
measure: Part 1: Plasma Concentration of JNJ-68179280 Under Fed Condition
timeFrame: Up to 13 days
measure: Part 1: Stool Concentration of JNJ-68179280 Under Fasted Condition
timeFrame: Up to Day 6
measure: Part 1: Stool Concentration of JNJ-68179280 Under Fed Condition
timeFrame: Up to 13 days
measure: Part 1: Number of Participants with TEAEs Under Fasted Condition
timeFrame: Up to 16 days
measure: Part 1: Number of Participants with TEAEs Under Fed Condition
timeFrame: Up to 23 days
measure: Part 1: Number of Participants with SAEs Under Fasted Condition
timeFrame: Up to 16 days
measure: Part 1: Number of Participants with SAEs Under Fed Condition
timeFrame: Up to 23 days
measure: Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fasted Condition
timeFrame: Up to 16 days
measure: Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fed Condition
timeFrame: Up to 23 days
measure: Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fasted Condition
timeFrame: Up to 16 days
measure: Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fed Condition
timeFrame: Up to 23 days
measure: Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fasted Condition
timeFrame: Up to 16 days
measure: Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fed Condition
timeFrame: Up to 23 days
measure: Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fasted Condition
timeFrame: Up to 16 days
measure: Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fed Condition
timeFrame: Up to 23 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: