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A Study to Evaluate the Effects of JNJ-54861911 on Electrocardiogram Intervals in Healthy Particiants

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: NCT02152332
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the effects of JNJ-54861911 on the QT/QTc intervals in healthy participants, when administered at therapeutic (50 milligram [mg] once-daily) and supratherapeutic (150 mg once-daily) doses for 7 days.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-54861911-Therapeutic Dose Drug: JNJ-54861911 - Supratherapeutic Dose Drug: JNJ-54861911-Matched Placebo Drug: Moxifloxacin Drug: Moxifloxacin Matched Placebo Phase 1

Detailed Description:
This is a Phase 1, double blind (a medical research study in which neither the researchers nor the participants know what treatment the participants is receiving), randomized (study drug assigned by chance), placebo and positive-controlled, multiple-dose, 4-way crossover (method used to switch participants from one study group to another) study. The study consists of 3 parts: Screening period (Days -21 to -2), Double-blind treatment period and End-of-study/early withdrawal assessment period (9 to 13 days after last dose). Treatment period will comprise of 4 treatment regimens each consisting of a baseline assessment and a treatment regime (Days -1 to 9). The participants will be randomly assigned to 1 of 4 treatment sequence groups (ADBC, BACD, CBDA, and DCAB) based on a computer-generated randomization schedule and will receive the following 4 treatments in the order specified by the randomization: Treatment A (JNJ-54861911, 50 milligram (mg) once daily for 7 days plus moxifloxacin-matched placebo on Day 7); Treatment B (JNJ-54861911, 150 mg once daily for 7 days plus moxifloxacin-matched placebo on Day 7); Treatment C (JNJ-54861911-matched placebo once daily for 7 days plus moxifloxacin-matched placebo on Day 7); Treatment D (JNJ-54861911-matched placebo once daily for 7 days plus moxifloxacin 400 mg on Day 7). Each treatment period will be separated by a washout period of at least 6 - 10 days. Total duration of study for a participant will be 93 days. Change from Baseline in QT/QTc intervals at Day 7 will be evaluated as primary end point. Participant's safety will be monitored throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo- and Positive-controlled, Multiple-dose, Four-way, Cross-over Study to Evaluate the Effects of Repeated Oral Doses of JNJ-54861911 on Electrocardiogram Intervals in Healthy Subjects
Study Start Date : July 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: Treatment Sequence Group ADBC
Participant 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).
Drug: JNJ-54861911-Therapeutic Dose
JNJ-54861911 50 mg once daily for 7 days in all treatment sequence.
Other Names:
  • RSC-385896
  • MTS-0385896A

Drug: JNJ-54861911 - Supratherapeutic Dose
JNJ-54861911 150 mg once daily for 7 days in all treatment sequence.
Other Names:
  • RSC-385896
  • MTS-0385896A

Drug: JNJ-54861911-Matched Placebo
JNJ-54861911-matched placebo once daily for 7 days in all treatment sequence.

Drug: Moxifloxacin
Moxifloxacin 400 mg on Day 7 in all treatment sequence.

Drug: Moxifloxacin Matched Placebo
Moxifloxacin matched placebo, 400 mg on Day 7 in all treatment sequence.

Experimental: Treatment Sequence Group BACD
Participant 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).
Drug: JNJ-54861911-Therapeutic Dose
JNJ-54861911 50 mg once daily for 7 days in all treatment sequence.
Other Names:
  • RSC-385896
  • MTS-0385896A

Drug: JNJ-54861911 - Supratherapeutic Dose
JNJ-54861911 150 mg once daily for 7 days in all treatment sequence.
Other Names:
  • RSC-385896
  • MTS-0385896A

Drug: JNJ-54861911-Matched Placebo
JNJ-54861911-matched placebo once daily for 7 days in all treatment sequence.

Drug: Moxifloxacin
Moxifloxacin 400 mg on Day 7 in all treatment sequence.

Drug: Moxifloxacin Matched Placebo
Moxifloxacin matched placebo, 400 mg on Day 7 in all treatment sequence.

Experimental: Treatment Sequence Group CBDA
Participant 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).
Drug: JNJ-54861911-Therapeutic Dose
JNJ-54861911 50 mg once daily for 7 days in all treatment sequence.
Other Names:
  • RSC-385896
  • MTS-0385896A

Drug: JNJ-54861911 - Supratherapeutic Dose
JNJ-54861911 150 mg once daily for 7 days in all treatment sequence.
Other Names:
  • RSC-385896
  • MTS-0385896A

Drug: JNJ-54861911-Matched Placebo
JNJ-54861911-matched placebo once daily for 7 days in all treatment sequence.

Drug: Moxifloxacin
Moxifloxacin 400 mg on Day 7 in all treatment sequence.

Drug: Moxifloxacin Matched Placebo
Moxifloxacin matched placebo, 400 mg on Day 7 in all treatment sequence.

Experimental: Treatment Sequence Group DCAB
Participant 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).
Drug: JNJ-54861911-Therapeutic Dose
JNJ-54861911 50 mg once daily for 7 days in all treatment sequence.
Other Names:
  • RSC-385896
  • MTS-0385896A

Drug: JNJ-54861911 - Supratherapeutic Dose
JNJ-54861911 150 mg once daily for 7 days in all treatment sequence.
Other Names:
  • RSC-385896
  • MTS-0385896A

Drug: JNJ-54861911-Matched Placebo
JNJ-54861911-matched placebo once daily for 7 days in all treatment sequence.

Drug: Moxifloxacin
Moxifloxacin 400 mg on Day 7 in all treatment sequence.

Drug: Moxifloxacin Matched Placebo
Moxifloxacin matched placebo, 400 mg on Day 7 in all treatment sequence.




Primary Outcome Measures :
  1. Change From Baseline in QT/QTc interval at Day 7 [ Time Frame: Baseline and Day 7 ]

Secondary Outcome Measures :
  1. Change From Baseline in Other Electrocardiogram (ECG) Parameters at Day 7 [ Time Frame: Baseline and Day 7 ]
    Other ECG parameters included RR interval, PR interval and QRS interval.

  2. Maximum Plasma Concentration (C[max]ss) at Steady State [ Time Frame: 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 ]
    The C(max)ss is the maximum plasma concentration at steady state which will be observed during dosing interval.

  3. Minimum Plasma Concentration (C[min]ss) at Steady State [ Time Frame: 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 ]
    The C(min)ss is the minimum plasma concentration at steady state which will be observed during dosing interval.

  4. Trough Plasma Concentration (C[trough]) [ Time Frame: 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 ]
    Trough plasma concentration is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose.

  5. Time to Reach the Maximum Plasma Concentration (T[max]) [ Time Frame: 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 ]
    The T[max] is time to reach the observed maximum plasma concentration.

  6. Average Plasma Concentration at Steady State (C[avg]ss) [ Time Frame: 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 ]
    Average Plasma Concentration at Steady State (C[avg]ss) will be calculated as Area under the plasma concentration-time curve (AUC[tau]) divided by the dosing interval (tau).

  7. Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUC[tau]ss) [ Time Frame: 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 ]
    The AUC ([tau]ss) is the area under the plasma concentration time curve observed during a dosing interval.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 willing to participate in the study
  • If a woman, must be either a) Not of childbearing potential: postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone [FSH] >40 international units per milliliter [IU/mL])or surgically sterile; b) Of child-bearing potential and be practicing an effective method of birth control
  • If a man, who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator
  • An average of triplicate 12-lead electrocardiogram (ECG) recordings, completed within 4 minutes total, consistent with normal cardiac conduction and function, including: a) normal sinus rhythm with heart rate between 45 and 100 beats per minutes (inclusive); b) QTcF interval between 350 to 450 milliseconds, inclusive; c) QRS interval of less than (<) 110 milliseconds; d) PR interval <200 milliseconds; e) PR interval <200 milliseconds; f) ECG morphology consistent with healthy cardiac conduction and function
  • Blood pressure (after the participants remains supine for 5 minutes) between 90 and 140 milimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic

Exclusion Criteria:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, gastro-intestinal disease, or any other illness that the investigator considers should exclude the parrticipants or that could interfere with the interpretation of the study results
  • History of additional risk factors for torsade de pointes or the presence of a family history of Short QT Syndrome, Long QT Syndrome, abnormal bleeding or blood clotting, sudden unexplained death at a young age (less than/equal to 40 years), drowning or sudden infant death syndrome in a first degree relative (that is, biological parent, sibling, or child)
  • Use of any prescription medication (with the exception of hormonal contraceptives or hormonal replacement therapy) within 14 days before Day -1 of Period 1; use of nonprescription medication (including vitamins and herbal supplements such as St. John's Wort) except for acetaminophen, within 30 days before Day -1 of Period 1; acetaminophen within 3 days of study drug administration in each treatment period
  • Clinically significant abnormal values for hematology, clinical chemistry (including hypo- or hyperkalemia, -magnesemia, or -calcemia) or urinalysis at Screening or at admission to the study center for Period 1 as deemed appropriate by the Investigator
  • Clinically significant abnormal physical examination, vital signs or 12-lead ECG at Screening or at admission to the study center for Period 1 as deemed appropriate by the Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152332


Locations
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United States, Arizona
Tempe, Arizona, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trials Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02152332     History of Changes
Other Study ID Numbers: CR104508
54861911ALZ1007 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: November 2014

Keywords provided by Janssen Research & Development, LLC:
JNJ-54861912
RSC-385896
MTS-0385896A
Phase 1
Moxifloxacin
Placebo
Healthy

Additional relevant MeSH terms:
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Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs