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JNJ-54861911-Therapeutic Dose

Phase 1

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: Nov 24, 2014

JNJ-54861911-Therapeutic Dose development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2014

JNJ-54861911-Therapeutic Dose target and mechanism

ModalitySmall molecule

Also known as RSC-385896, MTS-0385896A

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

JNJ-54861911-Therapeutic Dose clinical trials

JNJ-54861911-Therapeutic Dose · 1 trial · 1 indication

Phase 1 1
NCT02152332A Study to Evaluate the Effects of JNJ-54861911 on Electrocardiogram Intervals in Healthy ParticiantsHealthy
COMPLETED64 Analytics
PHASE1COMPLETED
A Study to Evaluate the Effects of JNJ-54861911 on Electrocardiogram Intervals in Healthy Particiants
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Study Endpoints

Primary Endpoints

Change From Baseline in QT/QTc interval at Day 7
Baseline and Day 7

Secondary Endpoints

Change From Baseline in Other Electrocardiogram (ECG) Parameters at Day 7
Baseline and Day 7
Maximum Plasma Concentration (C[max]ss) at Steady State
Pre-dose and 3 hour (hr) post dose on Day 1, 3, 5, and 7; 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 16, 24 hrs post dose on Day 7
Minimum Plasma Concentration (C[min]ss) at Steady State
Pre-dose and 3 hour (hr) post dose on Day 1, 3, 5, and 7; 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12, 16, 24 hrs post dose on Day 7
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Sequence Group ADBCEXPERIMENTALParticipant will receive Treatment A (JNJ-54861911, 50 milligram (mg) once daily for 7 days plus moxifloxacin-matched placebo on Day 7) followed by Treatment D (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin 400 mg on Day 7 of second treatment regimen, then Treatment B (JNJ-54861911, 150 mg once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of third treatment regimen followed by Treatment C (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of fourth treatment regimen).
Treatment Sequence Group BACDEXPERIMENTALParticipant will receive Treatment B (JNJ-54861911, 150 mg once daily for 7 days plus moxifloxacin-matched placebo on Day 7) followed by Treatment A (JNJ-54861911, 50 mg once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of second treatment regimen), then Treatment C (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of third treatment regimen) followed by followed by Treatment D (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin 400 mg on Day 7 of fourth treatment regimen).
Treatment Sequence Group CBDAEXPERIMENTALParticipant will receive Treatment C (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin-matched placebo on Day 7) followed by Treatment B (JNJ-54861911, 150 mg once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 on second treatment regimen), then Treatment D (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin 400 mg on Day 7 of third treatment regimen) followed by Treatment A (JNJ-54861911, 50 mg once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of fourth treatment regimen).
Treatment Sequence Group DCABEXPERIMENTALParticipant will receive Treatment D (JNJ-54861911-matched placebo once daily for 7 days plus moxifloxacin 400 mg on Day 7) followed by Treatment C (JNJ-54861911-matched placebo once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of second treatment regimen), then Treatment A (JNJ-54861911, 50 mg once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 of third treatment regimen) followed by Treatment B (JNJ-54861911, 150 mg once daily for next 7 days plus moxifloxacin-matched placebo on Day 7 on fourth treatment regimen).

Interventions

NameTypeDescription
JNJ-54861911-Therapeutic DoseDRUGJNJ-54861911 50 mg once daily for 7 days in all treatment sequence.
JNJ-54861911 - Supratherapeutic DoseDRUGJNJ-54861911 150 mg once daily for 7 days in all treatment sequence.
JNJ-54861911-Matched PlaceboDRUGJNJ-54861911-matched placebo once daily for 7 days in all treatment sequence.
MoxifloxacinDRUGMoxifloxacin 400 mg on Day 7 in all treatment sequence.
Moxifloxacin Matched PlaceboDRUGMoxifloxacin matched placebo, 400 mg on Day 7 in all treatment sequence.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Signed an informed consent document indicating they understand the purpose of and procedures required for the study, including the required pharmacogenomics component (which specifies testing of genes predisposing to long or short QT and related cardiac syndromes), and are wil...

Countries:United States
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Frequently asked questions about JNJ-54861911-Therapeutic Dose

What is JNJ-54861911-Therapeutic Dose?

JNJ-54861911-Therapeutic Dose is an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial evaluating its effects on electrocardiogram intervals in healthy adult participants. The specific therapeutic indication for this dose has not been disclosed.

Who is developing JNJ-54861911-Therapeutic Dose?

JNJ-54861911-Therapeutic Dose is being developed by Johnson & Johnson, which trades under the ticker symbol JNJ. The company sponsored the Phase 1 trial of this asset.

What phase is JNJ-54861911-Therapeutic Dose in?

JNJ-54861911-Therapeutic Dose is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is JNJ-54861911-Therapeutic Dose in?

JNJ-54861911-Therapeutic Dose has been evaluated in one completed Phase 1 trial, NCT02152332, titled A Study to Evaluate the Effects of JNJ-54861911 on Electrocardiogram Intervals in Healthy Participants. The trial enrolled 64 healthy volunteers in the United States and was randomized, double-blind, and controlled.

What is JNJ-54861911-Therapeutic Dose used for?

The therapeutic indication for JNJ-54861911-Therapeutic Dose has not been disclosed. Its only listed clinical trial studied its effects on electrocardiogram intervals in healthy participants, not in a patient population with a specific disease.