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A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54175446 in Healthy Male 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: NCT02515955
Recruitment Status : Completed
First Posted : August 5, 2015
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Tracking Information
First Submitted Date  ICMJE August 3, 2015
First Posted Date  ICMJE August 5, 2015
Last Update Posted Date June 6, 2016
Study Start Date  ICMJE August 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2015)
  • Number of Participants with Adverse Events [ Time Frame: Baseline up to 14 or 21 days after study drug administration ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Baseline up to Day 17 ]
    The Cmax is the maximum observed concentration.
  • Minimum Observed Plasma Concentration (Cmin) [ Time Frame: Baseline up to Day 17 ]
    The Cmin is the minimum observed plasma concentration.
  • Trough Plasma Concentration (Ctrough) [ Time Frame: Baseline up to Day 17 ]
    The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.
  • Average Plasma Concentration at Steady State (Cavg,ss) [ Time Frame: Baseline up to Day 17 ]
    The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Baseline up to Day 17 ]
    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: Baseline up to Day 17 ]
    The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
  • Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) [ Time Frame: Baseline up to Day 17 ]
    The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
  • Elimination Half-Life (t1/2) [ Time Frame: Baseline up to Day 17 ]
    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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02515955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54175446 in Healthy Male Participants
Official Title  ICMJE A Randomized, Placebo- and Comparator-controlled, Double-blind, Multiple (Ascending) Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54175446 in Healthy Male Subjects
Brief Summary The purpose of this study is to investigate the safety, tolerability and pharmacodynamics of JNJ-54175446 after multiple consecutive dose administrations
Detailed Description This will be a randomized, placebo-and comparator-controlled, double-blind, multiple dose study with JNJ-54175446 in healthy male participants. The study will consist of a Screening examination (28 to 6 days prior to dose administration), a baseline 20 mg amphetamine (AMPH) challenge at least 5 days before first dose administration, a double-blind treatment period (18 days; 11 days of dosing with JNJ-54175446, minocycline or placebo; amphetamine (AMPH)/AMPH placebo challenge sequence on Day 7 and Day 10 for each participant), and a follow-up examination between 14 and 21 days after last dose administration. The maximal study duration for each participant will not exceed 9 weeks. Safety, pharmacokinetics (PK) and pharmacodynamics of JNJ-54175446 will be primarily assessed. Safety will be monitored throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: JNJ-54175446
    Participants will receive JNJ-54175446, at increasing dose levels using 2 oral formulations i.e. 0.5 mg/ml and 20 mg/ml as suspension for oral dose once daily.
  • Drug: Minocycline
    Participants will receive minocycline 100 mg as capsule twice daily.
  • Drug: JNJ 54175446 Matching Placebo
    Participants will receive placebo matching with JNJ 54175446 once daily orally.
  • Drug: D Amphetamine
    Participants will receive 20 mg d-amphetamine (AMPH) 2 hours after administration of study drug (JNJ-54175446/placebo or minocycline/placebo) on Day 7 and Day 10.
  • Drug: D Amphetamine Matching Placebo
    Participants will receive d-amphetamine (AMPH) matching placebo, 2 hours after administration of study drug (JNJ-54175446/placebo or minocycline/placebo) on Day 7 and Day 10.
Study Arms  ICMJE
  • Experimental: Cohort 1
    Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
    Interventions:
    • Drug: JNJ-54175446
    • Drug: Minocycline
    • Drug: JNJ 54175446 Matching Placebo
    • Drug: D Amphetamine
    • Drug: D Amphetamine Matching Placebo
  • Experimental: Cohort 2
    Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
    Interventions:
    • Drug: JNJ-54175446
    • Drug: Minocycline
    • Drug: JNJ 54175446 Matching Placebo
    • Drug: D Amphetamine
    • Drug: D Amphetamine Matching Placebo
  • Experimental: Cohort 3
    Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
    Interventions:
    • Drug: JNJ-54175446
    • Drug: Minocycline
    • Drug: JNJ 54175446 Matching Placebo
    • Drug: D Amphetamine
    • Drug: D Amphetamine Matching Placebo
  • Experimental: Cohort 4
    Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
    Interventions:
    • Drug: JNJ-54175446
    • Drug: Minocycline
    • Drug: JNJ 54175446 Matching Placebo
    • Drug: D Amphetamine
    • Drug: D Amphetamine Matching Placebo
  • Experimental: Cohort 5
    Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
    Interventions:
    • Drug: JNJ-54175446
    • Drug: Minocycline
    • Drug: JNJ 54175446 Matching Placebo
    • Drug: D Amphetamine
    • Drug: D Amphetamine Matching Placebo
  • Experimental: Cohort 6
    Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or minocycline 100 mg capsule twice daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
    Interventions:
    • Drug: JNJ-54175446
    • Drug: Minocycline
    • Drug: JNJ 54175446 Matching Placebo
    • Drug: D Amphetamine
    • Drug: D Amphetamine Matching Placebo
  • Experimental: Cohort 7
    Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
    Interventions:
    • Drug: JNJ-54175446
    • Drug: JNJ 54175446 Matching Placebo
    • Drug: D Amphetamine
    • Drug: D Amphetamine Matching Placebo
  • Experimental: Cohort 8
    Participants will be receiving either JNJ-54175446 at increasing dose levels using 2 oral formulation as suspension for oral dose once daily from Day 1 to Day 17 or placebo matching with JNJ 54175446 once daily from Day 1 to Day 17.
    Interventions:
    • Drug: JNJ-54175446
    • Drug: JNJ 54175446 Matching Placebo
    • Drug: D Amphetamine
    • Drug: D Amphetamine Matching Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2015)
76
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant must have a body mass index (BMI) between 18 and 32 kilogram/meter^2 (kg/m^2), inclusive (BMI = weight/height^2)
  • Participants must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) [including QTcF less than or equal to 450 millisecond (ms) (triplicate 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 [including liver enzymes], 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. This determination must be recorded in the subject's source documents and initialed by the investigator
  • 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 e.g., 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, and 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

Exclusion Criteria:

  • Participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness that the Investigator considers should exclude the subject
  • Participant has a clinically significant (history of) psychiatric illnesses or (history of) psychotic symptoms
  • Participant has a family history of relevant psychiatric disorders (first degree) and/or psychotic disorders (first and second degree)
  • 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 a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02515955
Other Study ID Numbers  ICMJE CR107762
54175446EDI1002 ( Other Identifier: Janssen-Cilag International NV )
2015-001300-55 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen-Cilag International NV
Study Sponsor  ICMJE Janssen-Cilag International NV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen-Cilag International NV Clinical trials Janssen-Cilag International NV
PRS Account Janssen-Cilag International NV
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP