A Study of JNJ-70033093 in Healthy Participants

  • STATUS
    Recruiting
  • participants needed
    24
  • sponsor
    Janssen Research & Development, LLC
Updated on 19 February 2024
hysterectomy
systolic blood pressure
oophorectomy
human chorionic gonadotropin
electrocardiogram
drug test
diastolic blood pressure
tubal occlusion
bilateral salpingectomy
12 lead electrocardiogram
human chorionic gonadotropin, beta subunit
salpingectomy, bilateral

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of a single dose of JNJ-70033093 spray dried dispersion (SDD) tablets compared with JNJ-70033093 SDD granule capsules in healthy participants under fasting conditions in Part 1 and 2 and to assess the effect of food on the bioavailability of a single dose of JNJ-70033093 SDD tablets in Part 1.

Details
Condition Healthy
Age 18years - 55years
Treatment JNJ-70033093
Clinical Study IdentifierNCT04448964
SponsorJanssen Research & Development, LLC
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and on Day -1 of Treatment Period 1. If there are abnormalities, the investigator may decide that the abnormalities or deviations from normal are not clinically significant, in which case the participant may be included
Healthy on the basis of safety laboratory tests performed at screening and on Day -1 of Period 1. If the results of the safety laboratory tests 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
If a woman, must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and urine pregnancy test on Day 1 of each treatment period
Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2), and body weight not less than 50 kg at screening
After being supine for 5 minutes, systolic blood pressure between 90 and 140 millimeter of Mercury (mmHg), inclusive; and no higher than 90 mmHg diastolic blood pressure at screening and on Day -1 of Treatment Period 1
Must sign an ICF indicating that they understand the purpose of, and procedures required for the study and is willing to participate in the study
Before randomization, a woman must be either: a.) Not of childbearing potential (Postmenopausal- no menses for 12 months without an alternative medical cause and Permanently sterile- include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy); b.) of childbearing potential and practicing a highly effective method of contraception for at least 3 months prior to the study entry and agrees to remain on a highly effective method of contraception throughout the study and for at least 34 days after the last dose of study drug
During the study, a man who is sexually active with a woman of childbearing potential or with a woman who is pregnant must agree to use a barrier method of contraception

Exclusion Criteria

History of any known illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments
History of any clinically significant drug or food allergies (such as anaphylaxis or hepatotoxicity) and known allergy to the study drugs or any of the excipients of the formulation
History of allergy to or unwillingness to consume any component of the standardized high-fat breakfast menu to be provided in this study
Use of any systemic strong cytochrome P450 P glycoprotein ([CYP] 3A4/P-gp) inducers (example, [rifampin]) or inhibitors (example, [itraconazole]) within 4 weeks before the first dose of the study drug
Participants with current hepatitis B infection (confirmed by hepatitis B surface antigen [HBsAg]), or hepatitis C infection (confirmed by hepatitis C virus [HCV] antibody), or human immunodeficiency virus type 1 (HIV-1) or human immunodeficiency virus type 2 (HIV-2) infection at study screening
Clinically significant abnormal values for hematology, coagulation, clinical chemistry or urinalysis at screening or on Day -1 of Treatment Period 1 as determined by the investigator or appropriate designee
Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for hormonal contraceptives, hormone replacement therapy and paracetamol (acetaminophen) within 14 days before the first dose of the study drug until completion of the study
Any of the following on a 12-lead electrocardiogram (ECG) and the assessment of QT interval, confirmed by repeat at screening and Day -1 of Treatment Period 1: a.) Heart rate greater than (>) 100 beats per minute (bpm); b.) PR > 210 milliseconds (ms); c.) QRS > 120 ms; d.) QT corrected according to Fridericia's formula (QTcF) > 450 ms for male and > 470 ms for female
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