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| ID | Type | Description | Link |
|---|---|---|---|
| 54861911ALZ1007 | Other Identifier | Janssen Research & Development, LLC |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence Group ADBC | Experimental | 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). |
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| Treatment Sequence Group BACD | Experimental | 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). |
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| Treatment Sequence Group CBDA | Experimental | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-54861911-Therapeutic Dose | Drug | JNJ-54861911 50 mg once daily for 7 days in all treatment sequence. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in QT/QTc interval at Day 7 | Baseline and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Other Electrocardiogram (ECG) Parameters at Day 7 | Other ECG parameters included RR interval, PR interval and QRS interval. | Baseline and Day 7 |
| Maximum Plasma Concentration (C[max]ss) at Steady State |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trials | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
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| Treatment Sequence Group DCAB | Experimental | 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). |
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| JNJ-54861911 - Supratherapeutic Dose | Drug | JNJ-54861911 150 mg once daily for 7 days in all treatment sequence. |
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| JNJ-54861911-Matched Placebo | Drug | JNJ-54861911-matched placebo once daily for 7 days in all treatment sequence. |
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| Moxifloxacin | Drug | Moxifloxacin 400 mg on Day 7 in all treatment sequence. |
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| Moxifloxacin Matched Placebo | Drug | Moxifloxacin matched placebo, 400 mg on Day 7 in all treatment sequence. |
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The C(max)ss is the maximum plasma concentration at steady state which will be observed during dosing interval.
| 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 | The C(min)ss is the minimum plasma concentration at steady state which will be observed during dosing interval. | 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 (C[trough]) | 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. | 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 |
| Time to Reach the Maximum Plasma Concentration (T[max]) | The T[max] is time to reach the observed maximum plasma concentration. | 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) | 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). | 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 |
| Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUC[tau]ss) | The AUC ([tau]ss) is the area under the plasma concentration time curve observed during a dosing interval. | 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 |
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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