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Completed

NCT Number: NCT04844463

A Study of JNJ-68179280 in Healthy Participants

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).

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-68179280

Drug

JNJ-68179280 will be administered as an oral capsule.

Placebo

Other

Matching placebo will be administered as an oral capsule.

Primary outcomes

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

    Time frame: Up to 35 days

    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.

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

    Time frame: Up to 35 days

    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.

  3. Number of Participants with Clinically Significant Abnormalities in Vital Signs

    Time frame: Up to 35 days

    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.

  4. Number of Participants with Clinically Significant Abnormalities in Physical Examination

    Time frame: Up to 35 days

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

  5. Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests

    Time frame: Up to 35 days

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

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

    Time frame: Up to 28 days

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

Secondary outcomes

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

    Time frame: Up to 19 days

    Plasma concentration of JNJ-68179280 will be reported.

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

    Time frame: Up to 19 days

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

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

    Time frame: Up to 16 days

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

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

    Time frame: Up to Day 6

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

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

    Time frame: Up to 13 days

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

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

    Time frame: Up to Day 6

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

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

    Time frame: Up to 13 days

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

  8. Part 1: Number of Participants with TEAEs Under Fasted Condition

    Time frame: Up to 16 days

    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.

  9. Part 1: Number of Participants with TEAEs Under Fed Condition

    Time frame: Up to 23 days

    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.

  10. Part 1: Number of Participants with SAEs Under Fasted Condition

    Time frame: Up to 16 days

    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.

  11. Part 1: Number of Participants with SAEs Under Fed Condition

    Time frame: Up to 23 days

    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.

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

    Time frame: Up to 16 days

    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.

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

    Time frame: Up to 23 days

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

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

    Time frame: Up to 16 days

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

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

    Time frame: Up to 23 days

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

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

    Time frame: Up to 16 days

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

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

    Time frame: Up to 23 days

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

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

    Time frame: Up to 16 days

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

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

    Time frame: Up to 23 days

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

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2021
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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