A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55308942 in Healthy Male and Female Participants

NCT ID: NCT03151486

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-03
• Study Completion Date: 2018-03-08

Brief Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-55308942 in healthy participants after administration of single and multiple oral doses.

Conditions

Healthy

Study Design

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

Study Groups

Cohort 1:JNJ-55308942 0.5 mg or Placebo (SAD Part)

Participants will be randomized to receive a single dose of JNJ-55308942 0.5 milligrams (mg) or matching placebo as an oral solution after an overnight fast on Day 1 of Cohort 1 after single ascending dose (SAD).

Group Type: EXPERIMENTAL

JNJ-55308942 0.5 mg

Intervention Type: DRUG

Participants will receive JNJ-55308942 0.5 mg as an oral solution after an overnight fast on Day 1.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo in all cohorts.

Cohort 2: JNJ-55308942 1.5 mg or Placebo (SAD Part)

Participants will be randomized to receive a single dose of JNJ-55308942 1.5 mg or matching placebo as an oral solution after an overnight fast on Day 1.

Group Type: EXPERIMENTAL

JNJ-55308942 1.5 mg

Intervention Type: DRUG

Participants will receive JNJ-55308942 1.5 mg as an oral solution after an overnight fast on Day 1.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo in all cohorts.

Cohort 3: JNJ-55308942 4 mg or Placebo (SAD Part)

Participants will be randomized to receive a single dose of JNJ-55308942 4 mg or matching placebo as an oral solution after an overnight fast on Day 1.

Group Type: EXPERIMENTAL

JNJ-55308942 4 mg

Intervention Type: DRUG

Participants will receive JNJ-55308942 4 mg as an oral solution after an overnight fast on Day 1.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo in all cohorts.

Cohort 4: (JNJ-55308942 12 mg or Placebo (SAD Part))

Participants will be randomized to receive a single dose of JNJ-55308942 12 mg or matching placebo as an oral solution after an overnight fast on Day 1.

Group Type: EXPERIMENTAL

JNJ-55308942 12 mg

Intervention Type: DRUG

Participants will receive JNJ-55308942 12 mg as an oral solution after an overnight fast on Day 1.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo in all cohorts.

Cohort 5: JNJ-55308942 36 mg or Placebo (SAD Part)

Participants will be randomized to receive a single dose of JNJ-55308942 36 mg or matching placebo as an oral solution after an overnight fast on Day 1.

Group Type: EXPERIMENTAL

JNJ-55308942 36 mg

Intervention Type: DRUG

Participants will receive JNJ-55308942 36 mg as an oral solution after an overnight fast on Day 1.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo in all cohorts.

Cohort 6: JNJ-55308942 100 mg or Placebo (SAD Part)

Participants will be randomized to receive a single dose of JNJ-55308942 100 mg or matching placebo as an oral solution after an overnight fast on Day 1.

Group Type: EXPERIMENTAL

JNJ-55308942 100 mg

Intervention Type: DRUG

Participants will receive a single oral dose of JNJ-55308942 100 mg as an oral solution after an overnight fast on Day 1.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo in all cohorts.

Cohort 7: JNJ-55308942 or Placebo (SAD Part)

Participants will be randomized to receive a single dose of JNJ-55308942 or matching placebo as an oral solution in a fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts.

Group Type: EXPERIMENTAL

JNJ-55308942: Fed State

Intervention Type: DRUG

Participants will receive JNJ-55308942 as an oral solution in fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo in all cohorts.

Cohort 1: JNJ-55308942 or Placebo (MAD Part)

Participants will be randomized to receive JNJ-55308942 or matching placebo once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the multiple ascending doses (MAD) will be determined based on the data from the SAD part.

Group Type: EXPERIMENTAL

JNJ-55308942: MAD Part

Intervention Type: DRUG

Participants will receive JNJ-55308942 once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo in all cohorts.

Cohort 2: JNJ-55308942 or Placebo (MAD Part)

Participants will be randomized to receive JNJ-55308942 or matching placebo once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part.

Group Type: EXPERIMENTAL

JNJ-55308942: MAD Part

Intervention Type: DRUG

Participants will receive JNJ-55308942 once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo in all cohorts.

Cohort 3: JNJ-55308942 or Placebo (MAD Part)

Participants will be randomized to receive JNJ-55308942 or matching placebo once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part.

Group Type: EXPERIMENTAL

JNJ-55308942: MAD Part

Intervention Type: DRUG

Participants will receive JNJ-55308942 once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo in all cohorts.

Interventions

JNJ-55308942 0.5 mg

Participants will receive JNJ-55308942 0.5 mg as an oral solution after an overnight fast on Day 1.

Intervention Type: DRUG

JNJ-55308942 1.5 mg

Participants will receive JNJ-55308942 1.5 mg as an oral solution after an overnight fast on Day 1.

Intervention Type: DRUG

JNJ-55308942 4 mg

Participants will receive JNJ-55308942 4 mg as an oral solution after an overnight fast on Day 1.

Intervention Type: DRUG

JNJ-55308942 12 mg

Participants will receive JNJ-55308942 12 mg as an oral solution after an overnight fast on Day 1.

Intervention Type: DRUG

JNJ-55308942 36 mg

Participants will receive JNJ-55308942 36 mg as an oral solution after an overnight fast on Day 1.

Intervention Type: DRUG

JNJ-55308942 100 mg

Participants will receive a single oral dose of JNJ-55308942 100 mg as an oral solution after an overnight fast on Day 1.

Intervention Type: DRUG

JNJ-55308942: Fed State

Participants will receive JNJ-55308942 as an oral solution in fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts.

Intervention Type: DRUG

JNJ-55308942: MAD Part

Participants will receive JNJ-55308942 once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo in all cohorts.

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, neurological examination, medical history, vital signs, and 12 lead (electrocardiogram) ECG, and peripheral capillary oxygen saturation [(SpO2) greater than or equal to (>=) 97 percent] 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
• Female participants must not be of childbearing potential by fulfilling 1 of the criteria: 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 Unit per Liter (IU/L) or milli-International Unit 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
• Female participants must have a negative serum pregnancy (Beta -human chorionic gonadotropin [Beta -hCG]) test at screening and a negative urine pregnancy test on Day -1

Exclusion Criteria

• Participant has current, or history of, clinically significant medical illness including, but not limited to, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Participant has a history of abnormal bleeding or clotting, or disorder of fibrinogen (example, dysfibrinogenemia, hypofibrinogenemia)
• 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 that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence)
• Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month or within a period of less than 10 times the drug's half-life, whichever is longer, before the planned first dose of study drug, or is currently enrolled in another investigational study
• Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before Screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines, ecstasy, phencyclidine, tricyclic antidepressants, and benzodiazepines) at Screening

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

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2017-000303-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

55308942EDI1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108293

Identifier Type: -

Identifier Source: org_study_id