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

NCT03151486 | Completed Phase 1

• 3 other identifiers: CR1082932017-000303-2555308942EDI1001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (16)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  Up to 6 Weeks

• Single Ascending Dose (SAD): Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942

  The Cmax is the maximum observed plasma concentration of JNJ-55308942.

  Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1

• SAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942

  Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.

  Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1

• SAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-55308942

  AUC (0-24h) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to 24 hours postdose.

  Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1

• SAD: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Observed Quantifiable Concentration (AUC [0-Last]) of JNJ-55308942

  AUC (0-last) is defined as area under the plasma JNJ-53308942 concentration-time curve from time 0 to time of the last observed quantifiable concentration.

  Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1

• SAD: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-55308942

  AUC (0-infinity) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to infinite time.

  Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1

• SAD: Area Under the Plasma JNJ-55308942 Concentration-time Curve During a Dosing Interval (t) at steady-state (AUC tau)

  AUC tau is defined as area under the plasma JNJ-55308942 concentration-time curve during a dosing interval (tau) at steady-state.

  Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1

• SAD: Apparent elimination Half-Life (t1/2) of JNJ-55308942

  The elimination half-life (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

  Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1

• Multiple Ascending Dose (MAD): Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942 on Day 1

  The Cmax is the maximum observed plasma concentration of JNJ-55308942.

  Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1

• MAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942 on Day 1

  Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.

  Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1

• MAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-55308942 on Day 1

  AUC (0-24h) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to 24 hours postdose.

  Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1

• MAD: Apparent elimination Half-Life (t1/2) of JNJ-55308942 on Day 1

  The elimination half-life (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

  Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1

• MAD: Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942 After Dosing on Day 10

  The Cmax is the maximum observed plasma concentration of JNJ-55308942.

  Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10

• MAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942 After Dosing on Day 10

  Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.

  Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10

• MAD: Area Under the Plasma JNJ-55308942 Concentration-time Curve During a Dosing Interval (t) at steady-state (AUC tau) After Dosing on Day 10

  AUC tau is defined as area under the plasma JNJ-55308942 concentration-time curve during a dosing interval (tau) at steady-state.

  Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10

• MAD: Apparent Elimination Half-Life (t1/2) of JNJ-55308942 After Dosing on Day 10

  The elimination half-life (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

  Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10

Study Arms (10)

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

EXPERIMENTAL

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).

Drug: JNJ-55308942 0.5 mg; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: JNJ-55308942 1.5 mg; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: JNJ-55308942 4 mg; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: JNJ-55308942 12 mg; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: JNJ-55308942 36 mg; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: JNJ-55308942 100 mg; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: JNJ-55308942: Fed State; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: JNJ-55308942: MAD Part; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: JNJ-55308942: MAD Part; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: JNJ-55308942: MAD Part; Drug: Placebo

Interventions

JNJ-55308942 0.5 mg DRUG

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

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

JNJ-55308942 1.5 mg DRUG

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

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

JNJ-55308942 4 mg DRUG

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

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

JNJ-55308942 12 mg DRUG

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

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

JNJ-55308942 36 mg DRUG

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

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

JNJ-55308942 100 mg DRUG

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

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

JNJ-55308942: Fed State 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.

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

JNJ-55308942: MAD Part 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.

Cohort 1: JNJ-55308942 or Placebo (MAD Part); Cohort 2: JNJ-55308942 or Placebo (MAD Part); Cohort 3: JNJ-55308942 or Placebo (MAD Part)

Placebo DRUG

Participants will receive matching placebo in all cohorts.

Cohort 1: JNJ-55308942 or Placebo (MAD Part); Cohort 1:JNJ-55308942 0.5 mg or Placebo (SAD Part); Cohort 2: JNJ-55308942 1.5 mg or Placebo (SAD Part); Cohort 2: JNJ-55308942 or Placebo (MAD Part); Cohort 3: JNJ-55308942 4 mg or Placebo (SAD Part); Cohort 3: JNJ-55308942 or Placebo (MAD Part); Cohort 4: (JNJ-55308942 12 mg or Placebo (SAD Part)); Cohort 5: JNJ-55308942 36 mg or Placebo (SAD Part); Cohort 6: JNJ-55308942 100 mg or Placebo (SAD Part); Cohort 7: JNJ-55308942 or Placebo (SAD Part)

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

JNJ-55308942

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 12, 2017
• Study Start: May 3, 2017
• Primary Completion: March 8, 2018
• Study Completion: March 8, 2018
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

BE (1)