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A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54175446 in Healthy Male Participants

Information source: Janssen-Cilag International NV
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: JNJ-54175446 (Drug); Minocycline (Drug); JNJ 54175446 Matching Placebo (Drug); D Amphetamine (Drug); D Amphetamine Matching Placebo (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Janssen-Cilag International NV

Official(s) and/or principal investigator(s):
Janssen-Cilag International NV Clinical trials, Study Director, Affiliation: Janssen-Cilag International NV

Overall contact:
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: JNJ.CT@sylogent.com


The purpose of this study is to investigate the safety, tolerability and pharmacodynamics of JNJ-54175446 after multiple consecutive dose administrations

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Number of Participants with Adverse Events

Maximum Observed Plasma Concentration (Cmax)

Minimum Observed Plasma Concentration (Cmin)

Trough Plasma Concentration (Ctrough)

Average Plasma Concentration at Steady State (Cavg,ss)

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])

Elimination Half-Life (t1/2)

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.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.


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

Locations and Contacts

This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: JNJ.CT@sylogent.com

Leiden, Netherlands; Not yet recruiting
Additional Information

Starting date: August 2015
Last updated: August 3, 2015

Page last updated: August 20, 2015

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