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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: JNJ-64264681

Study type: Interventional

Funder types: Industry

Identifiers

NCT03607513

64264681EDI1003 (Other Identifier)

CR108457

2018-000428-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 58 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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105 participants in 2 patient groups

Single Ascending Dose (SAD)

Experimental group

Description:

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.

Treatment:

Drug: JNJ-64264681

Drug: Placebo

Multiple Ascending Dose (MAD)

Experimental group

Description:

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.

Treatment:

Drug: JNJ-64264681

Drug: Placebo