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

NCT ID: NCT02515955

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

JNJ-54175446

Intervention Type DRUG

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.

Minocycline

Intervention Type DRUG

Participants will receive minocycline 100 mg as capsule twice daily.

JNJ 54175446 Matching Placebo

Intervention Type DRUG

Participants will receive placebo matching with JNJ 54175446 once daily orally.

D Amphetamine

Intervention Type DRUG

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.

D Amphetamine Matching Placebo

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

JNJ-54175446

Intervention Type DRUG

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.

Minocycline

Intervention Type DRUG

Participants will receive minocycline 100 mg as capsule twice daily.

JNJ 54175446 Matching Placebo

Intervention Type DRUG

Participants will receive placebo matching with JNJ 54175446 once daily orally.

D Amphetamine

Intervention Type DRUG

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.

D Amphetamine Matching Placebo

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

JNJ-54175446

Intervention Type DRUG

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.

Minocycline

Intervention Type DRUG

Participants will receive minocycline 100 mg as capsule twice daily.

JNJ 54175446 Matching Placebo

Intervention Type DRUG

Participants will receive placebo matching with JNJ 54175446 once daily orally.

D Amphetamine

Intervention Type DRUG

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.

D Amphetamine Matching Placebo

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

JNJ-54175446

Intervention Type DRUG

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.

Minocycline

Intervention Type DRUG

Participants will receive minocycline 100 mg as capsule twice daily.

JNJ 54175446 Matching Placebo

Intervention Type DRUG

Participants will receive placebo matching with JNJ 54175446 once daily orally.

D Amphetamine

Intervention Type DRUG

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.

D Amphetamine Matching Placebo

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

JNJ-54175446

Intervention Type DRUG

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.

Minocycline

Intervention Type DRUG

Participants will receive minocycline 100 mg as capsule twice daily.

JNJ 54175446 Matching Placebo

Intervention Type DRUG

Participants will receive placebo matching with JNJ 54175446 once daily orally.

D Amphetamine

Intervention Type DRUG

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.

D Amphetamine Matching Placebo

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

JNJ-54175446

Intervention Type DRUG

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.

Minocycline

Intervention Type DRUG

Participants will receive minocycline 100 mg as capsule twice daily.

JNJ 54175446 Matching Placebo

Intervention Type DRUG

Participants will receive placebo matching with JNJ 54175446 once daily orally.

D Amphetamine

Intervention Type DRUG

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.

D Amphetamine Matching Placebo

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

JNJ-54175446

Intervention Type DRUG

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.

JNJ 54175446 Matching Placebo

Intervention Type DRUG

Participants will receive placebo matching with JNJ 54175446 once daily orally.

D Amphetamine

Intervention Type DRUG

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.

D Amphetamine Matching Placebo

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

JNJ-54175446

Intervention Type DRUG

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.

JNJ 54175446 Matching Placebo

Intervention Type DRUG

Participants will receive placebo matching with JNJ 54175446 once daily orally.

D Amphetamine

Intervention Type DRUG

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.

D Amphetamine Matching Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Minocycline

Participants will receive minocycline 100 mg as capsule twice daily.

Intervention Type DRUG

JNJ 54175446 Matching Placebo

Participants will receive placebo matching with JNJ 54175446 once daily orally.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen-Cilag International NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag International NV Clinical trials

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

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Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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54175446EDI1002

Identifier Type: OTHER

Identifier Source: secondary_id

2015-001300-55

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR107762

Identifier Type: -

Identifier Source: org_study_id

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