Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-61393215 in Healthy Participants

NCT02812251 | Completed Phase 1

• 3 other identifiers: CR10818261393215EDI10012016-000822-20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 versus placebo after single oral dose administration under fasted (ascending dose levels) and fed condition, to characterize the pharmacokinetics of JNJ-61393125 in plasma, cerebrospinal fluid (CSF) and urine after single oral dose administration and to investigate the effect of food (high fat/high calorie) on the pharmacokinetics of JNJ-61393215 following single oral dose administration.

Conditions

Healthy

Outcome Measures

Primary Outcomes (11)

• Number of Participants With Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability

  Up to follow-up phase (7 to 14 days after study drug administration)

• Maximum Plasma Concentration (Cmax) of JNJ-61393125

  The Cmax is the maximum observed plasma concentration.

  Up to Day 4

• Last Quantifiable Plasma Concentration (Clast) of JNJ-61393125

  The Clast is the last quantifiable plasma concentration.

  Up to Day 4

• Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-61393125

  The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  Up to Day 4

• Time of the Last Quantifiable Plasma Concentration (Tlast) of JNJ-61393125

  The Tlast is defined as the time of the last quantifiable plasma concentration.

  Up to Day 4

• Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration of JNJ-61393125

  The (AUC \[0-last\]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.

  Up to Day 4

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-61393125

  The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(0-last)/lambda(z), wherein AUC(0-last) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.

  Up to Day 4

• First Order Rate Constant (Lambda[z]) of JNJ-61393125

  Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

  Up to Day 4

• Elimination Half-life (t1/2) of JNJ-61393125

  Elimination half-life (t \[1/2\]) is associated with the terminal slope (lambda \[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).

  Up to Day 4

• Total Clearance (CL/F) of JNJ-61393125

  Total clearance of drug after extravascular administration, uncorrected for absolute bioavailability, calculated as: D/AUC infinity.

  Up to Day 4

• Creatinine Clearance (CLcr) of JNJ-61393125

  Up to Day 4

Secondary Outcomes (3)

• Change From Baseline in NeuroCart test battery Score

  Up to Day 2

• Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT Fatigue)

  Up to Day 2

• Visual Verbal Learning Test (VVLT) Score

  Up to Day 2

Study Arms (10)

Part 1: Cohort 1

EXPERIMENTAL

Participants will receive 1 milligram (mg) JNJ-61393215 or placebo.

Drug: JNJ-61393215; Drug: Placebo

Part 1: Cohort 2

EXPERIMENTAL

Participants will receive 5 mg JNJ-61393215 or placebo.

Drug: JNJ-61393215; Drug: Placebo

Part 1: Cohort 3

EXPERIMENTAL

Participants will receive 15 mg JNJ-61393215 or placebo.

Drug: JNJ-61393215; Drug: Placebo

Part 1: Cohort 4

EXPERIMENTAL

Participants will receive 30 mg JNJ-61393215 or placebo.

Drug: JNJ-61393215; Drug: Placebo

Part 1: Cohort 5

EXPERIMENTAL

Participants will receive 45 mg JNJ-61393215 or placebo.

Drug: JNJ-61393215; Drug: Placebo

Part 1: Cohort 6

EXPERIMENTAL

Participants will receive 60 mg JNJ-61393215 or placebo.

Drug: JNJ-61393215; Drug: Placebo

Part 1: Cohort 7

EXPERIMENTAL

Participants will receive 90 mg JNJ-61393215 or placebo.

Drug: JNJ-61393215; Drug: Placebo

Part 1: Cohort 8

EXPERIMENTAL

Participants will receive 120 mg JNJ-61393215 or placebo.

Drug: JNJ-61393215; Drug: Placebo

Part 2

EXPERIMENTAL

Participants will receive JNJ-61393215 (dose to be determined).

Drug: JNJ-61393215

Part 3

EXPERIMENTAL

Participants will receive JNJ-61393125 (dose to be determined) or placebo under fed conditions.

Drug: JNJ-61393215; Drug: Placebo

Interventions

JNJ-61393215 DRUG

JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.

Part 1: Cohort 1; Part 1: Cohort 2; Part 1: Cohort 3; Part 1: Cohort 4; Part 1: Cohort 5; Part 1: Cohort 6; Part 1: Cohort 7; Part 1: Cohort 8; Part 2; Part 3

Placebo DRUG

Matching placebo will be administered.

Part 1: Cohort 1; Part 1: Cohort 2; Part 1: Cohort 3; Part 1: Cohort 4; Part 1: Cohort 5; Part 1: Cohort 6; Part 1: Cohort 7; Part 1: Cohort 8; Part 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have a body mass index (BMI) between 18 and 30 kilogram per meter square kg/m\^2, inclusive (BMI = weight/height\^2)
• Participants must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities to be not clinically significant
• A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository during the study and for 3 months after receiving the last dose of study drug. All men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partner should also use an appropriate method of birth control for at least the same duration.
• Healthy male participants between 18 and 54 years of age, inclusive for Part 1 and 3
• Healthy male and female participants between 55 and 75 years of age, inclusive in Part 2

You may not qualify if:

• Participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic (including coagulation disorders), rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness. Minor deviations, which are not considered to be of clinical significance to both the investigator and to the Janssen Safety Responsible Physician, are acceptable
• Participant has estimated glomerular filtration rate (eGFR) less than (\<) 60 milliliters per minute per 1.73 meter square (mL/min/1.73m\^2) at Screening
• Participant has a heart rate less than (\<) 50 beats per minute (bpm) at Screening or at admission to the clinical unit
• Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening
• Participant has Left Bundle Branch Block (LBBB), Atrioventricular (AV) Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator \[ICD\]

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (1)

Unknown Facility

Leiden, Netherlands

Location

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 24, 2016
• Study Start: July 7, 2016
• Primary Completion: November 17, 2016
• Study Completion: November 17, 2016
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

NL (1)