A Study of JNJ-68179280 in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT04844463

Run by

Janssen Research & Development, LLC

People needed

94

Starts

2021-05-26

Expected to finish

2023-03-13

Last updated by the study team

2025-02-03

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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