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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JNJ-55308942 0.5 mg; Drug: JNJ-55308942 12 mg; Drug: JNJ-55308942 100 mg; Drug: JNJ-55308942 1.5 mg; Drug: JNJ-55308942 4 mg; Drug: JNJ-55308942 36 mg; Drug: Placebo

• Registration Number: NCT03151486
• Lead Sponsor: Janssen-Cilag International NV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-26
• Study Start: 2017-05-03
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Primary Completion: 2018-03-08
• Study Completion: 2018-03-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	Up to 6 Weeks	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Single Ascending Dose (SAD): Maximum Observed Plasma Concentration (Cmax) 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	The Cmax is the maximum observed plasma concentration of JNJ-55308942.
SAD: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) 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	AUC (0-infinity) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to infinite time.
SAD: Apparent elimination Half-Life (t1/2) 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	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).
SAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) 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	Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.
MAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942 on Day 1	Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1	Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.
MAD: Apparent Elimination Half-Life (t1/2) of JNJ-55308942 After Dosing on Day 10	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	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).
SAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-55308942	Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours postdose 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.
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	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	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.
SAD: Area Under the Plasma JNJ-55308942 Concentration-time Curve During a Dosing Interval (t) at steady-state (AUC tau)	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	AUC tau is defined as area under the plasma JNJ-55308942 concentration-time curve during a dosing interval (tau) at steady-state.
MAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-55308942 on Day 1	Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours postdose 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.
Multiple Ascending Dose (MAD): Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942 on Day 1	Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1	The Cmax is the maximum observed plasma concentration of JNJ-55308942.
MAD: Apparent elimination Half-Life (t1/2) of JNJ-55308942 on Day 1	Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose 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).
MAD: Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942 After Dosing on Day 10	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	The Cmax is the maximum observed plasma concentration of JNJ-55308942.
MAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942 After Dosing on Day 10	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	Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.
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	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	AUC tau is defined as area under the plasma JNJ-55308942 concentration-time curve during a dosing interval (tau) at steady-state.

Trial Locations

Locations (1)

Clinical Pharmacology Unit; 🇧🇪 Merksem, Belgium