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
Summary
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 EventsMaximum 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
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
|