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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812251
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-61393215 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-61393215 in Healthy Subjects
Actual Study Start Date : July 7, 2016
Actual Primary Completion Date : November 17, 2016
Actual Study Completion Date : November 17, 2016

Arm Intervention/treatment
Experimental: Part 1: Cohort 1
Participants will receive 1 milligram (mg) JNJ-61393215 or placebo.
Drug: JNJ-61393215
JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.

Drug: Placebo
Matching placebo will be administered.

Experimental: Part 1: Cohort 2
Participants will receive 5 mg JNJ-61393215 or placebo.
Drug: JNJ-61393215
JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.

Drug: Placebo
Matching placebo will be administered.

Experimental: Part 1: Cohort 3
Participants will receive 15 mg JNJ-61393215 or placebo.
Drug: JNJ-61393215
JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.

Drug: Placebo
Matching placebo will be administered.

Experimental: Part 1: Cohort 4
Participants will receive 30 mg JNJ-61393215 or placebo.
Drug: JNJ-61393215
JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.

Drug: Placebo
Matching placebo will be administered.

Experimental: Part 1: Cohort 5
Participants will receive 45 mg JNJ-61393215 or placebo.
Drug: JNJ-61393215
JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.

Drug: Placebo
Matching placebo will be administered.

Experimental: Part 1: Cohort 6
Participants will receive 60 mg JNJ-61393215 or placebo.
Drug: JNJ-61393215
JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.

Drug: Placebo
Matching placebo will be administered.

Experimental: Part 1: Cohort 7
Participants will receive 90 mg JNJ-61393215 or placebo.
Drug: JNJ-61393215
JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.

Drug: Placebo
Matching placebo will be administered.

Experimental: Part 1: Cohort 8
Participants will receive 120 mg JNJ-61393215 or placebo.
Drug: JNJ-61393215
JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.

Drug: Placebo
Matching placebo will be administered.

Experimental: Part 2
Participants will receive JNJ-61393215 (dose to be determined).
Drug: JNJ-61393215
JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.

Experimental: Part 3
Participants will receive JNJ-61393125 (dose to be determined) or placebo under fed conditions.
Drug: JNJ-61393215
JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.

Drug: Placebo
Matching placebo will be administered.




Primary Outcome Measures :
  1. Number of Participants With Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to follow-up phase (7 to 14 days after study drug administration) ]
  2. Maximum Plasma Concentration (Cmax) of JNJ-61393125 [ Time Frame: Up to Day 4 ]
    The Cmax is the maximum observed plasma concentration.

  3. Last Quantifiable Plasma Concentration (Clast) of JNJ-61393125 [ Time Frame: Up to Day 4 ]
    The Clast is the last quantifiable plasma concentration.

  4. Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-61393125 [ Time Frame: Up to Day 4 ]
    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  5. Time of the Last Quantifiable Plasma Concentration (Tlast) of JNJ-61393125 [ Time Frame: Up to Day 4 ]
    The Tlast is defined as the time of the last quantifiable plasma concentration.

  6. Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration of JNJ-61393125 [ Time Frame: Up to Day 4 ]
    The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.

  7. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-61393125 [ Time Frame: Up to Day 4 ]
    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.

  8. First Order Rate Constant (Lambda[z]) of JNJ-61393125 [ Time Frame: Up to Day 4 ]
    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.

  9. Elimination Half-life (t1/2) of JNJ-61393125 [ Time Frame: Up to Day 4 ]
    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).

  10. Total Clearance (CL/F) of JNJ-61393125 [ Time Frame: Up to Day 4 ]
    Total clearance of drug after extravascular administration, uncorrected for absolute bioavailability, calculated as: D/AUC infinity.

  11. Creatinine Clearance (CLcr) of JNJ-61393125 [ Time Frame: Up to Day 4 ]

Secondary Outcome Measures :
  1. Change From Baseline in NeuroCart test battery Score [ Time Frame: Up to Day 2 ]
    Effects of JNJ-61393215 on alertness/sedation will be assessed by means of the NeuroCart test battery (including pharmaco-electroencephalogram [EEG], saccadic eye movements, smooth pursuit, adaptive tracking, body sway, Bond & Lader Visual Analogue Scale (VAS), Bowdle VAS, Swiss Narcolepsy Scale [SNS]).

  2. Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT Fatigue) [ Time Frame: Up to Day 2 ]
    The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The total FACIT-Fatigue score ranges from 0 to 52, with a higher score indicating less fatigue.

  3. Visual Verbal Learning Test (VVLT) Score [ Time Frame: Up to Day 2 ]
    Assessment of cognition will be done by Visual Verbal Learning Test (VVLT) which includes 30 words in three consecutive word trials and the participants will be assessed for Immediate Recall and Delayed Recognition.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants must have a body mass index (BMI) between 18 and 30 kilogram per meter square kg/m^2, inclusive (BMI = weight/height^2)
  • Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening and admission to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable. The presence of Left Bundle Branch Block (LBBB), Atrioventricular (AV) Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator [ICD] will lead to exclusion
  • 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

Exclusion Criteria:

  • 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]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812251


Locations
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Netherlands
Leiden, Netherlands
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
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Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
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Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT02812251    
Other Study ID Numbers: CR108182
61393215EDI1001 ( Other Identifier: Janssen-Cilag International NV )
2016-000822-20 ( EudraCT Number )
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No