A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64264681 in Healthy Male and Female Participants

NCT ID: NCT03607513

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2019-08-09

Brief Summary

The primary purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JNJ-64264681 in healthy participants after single and multiple oral doses.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Single Ascending Dose (SAD)

The SAD part will consist of 6 escalating dose cohorts and 1 fed cohort of healthy male participants, 2 dose escalating cohorts of healthy female participants, and 1 solid dose formulation (capsule) cohort of healthy male participants, who will be dosed after completion of the dose escalation cohorts. Participants in each cohort (except for the solid dose formulation cohort) will receive JNJ-64264681 or Placebo on Day 1, orally. In the solid dose formulation cohort, participants will receive JNJ-64264681 capsule on Day 1. Doses for the female cohorts and fed cohort will be selected based on safety, tolerability, pharmacokinetics (PK),and pharmacodynamic (PD) data from preceding cohorts and the dose for the solid dose formulation cohort will be selected and approximately equal to a dose previously studied in the single ascending dose cohorts.

Group Type: EXPERIMENTAL

JNJ-64264681

Intervention Type: DRUG

For all cohorts except the solid dose formulation cohort, JNJ-64264681 wlll be administered as oral solution. For the solid dose formulation cohort, JNJ-64264681 will be provided as capsules for oral administration.

Placebo

Intervention Type: DRUG

Matching placebo to JNJ-64264681 will be administered as oral solution.

Multiple Ascending Dose (MAD)

The MAD part will consist of 3 dose escalation cohorts of males and females. Participants will receive once-daily oral doses of JNJ-64264681 or placebo for 10 consecutive days.

Group Type: EXPERIMENTAL

JNJ-64264681

Intervention Type: DRUG

For all cohorts except the solid dose formulation cohort, JNJ-64264681 wlll be administered as oral solution. For the solid dose formulation cohort, JNJ-64264681 will be provided as capsules for oral administration.

Placebo

Intervention Type: DRUG

Matching placebo to JNJ-64264681 will be administered as oral solution.

Interventions

JNJ-64264681

For all cohorts except the solid dose formulation cohort, JNJ-64264681 wlll be administered as oral solution. For the solid dose formulation cohort, JNJ-64264681 will be provided as capsules for oral administration.

Intervention Type: DRUG

Placebo

Matching placebo to JNJ-64264681 will be administered as oral solution.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant must have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (BMI = weight[kg]/height[m]^2), and a body weight of not less than 50 kilogram (kg)
• Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) performed at screening and Day -1
• Participant must be healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, coagulation, hematology, 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. This determination must be recorded in the participant's source documents and initialed by the investigator
• Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
• Female participants must not be of childbearing potential by fulfilling 1 of the criteria below: a) Be over 45 years of age with no menses for 12 months without an alternative medical cause, with screening follicle stimulating hormone (FSH) levels of greater than (>)40 International Units Per Liter (IU/L) or milli-international units per milliliter (mIU/mL). b) Be permanently surgically sterile. Permanent surgical sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. Documentation of FSH levels is not required in the case of surgical sterility

Exclusion Criteria

• Participant has current, or history of clinically significant medical illness including, but not limited to, liver or renal insufficiency, significant cardiac (including heart valve disease), vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Participant has a history of abnormal bleeding or bruising
• Participant has a history of atrial fibrillation or history of arrhythmias
• Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
• Participant has known allergies, hypersensitivity, or intolerance to polyethylene glycol 400 (PEG400) (vehicle for JNJ-64264681 for oral solution dosing) for participant in a cohort where study drug is to be dosed as an oral solution, or to microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, silica dioxide, sodium lauryl sulfate, magnesium stearate, or gelatin (excipients in the solid dose formulation (capsule) of JNJ-64264681) for participant in a solid dose formulation cohort

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2018-000428-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64264681EDI1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR108457

Identifier Type: -

Identifier Source: org_study_id