HealthyPhase 1NCT02152332
A Study to Evaluate the Effects of JNJ-54861911 on Electrocardiogram Intervals in Healthy Particiants
A Phase 1 study testing JNJ-54861911-Therapeutic Dose, JNJ-54861911 - Supratherapeutic Dose and Moxifloxacin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-54861911-Therapeutic Dose, JNJ-54861911 - Supratherapeutic Dose and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- JNJ-54861911-Therapeutic Dose, JNJ-54861911 - Supratherapeutic Dose, JNJ-54861911-Matched Placebo, Moxifloxacin, Moxifloxacin Matched Placebo
- Keywords
- JNJ-54861912, RSC-385896, MTS-0385896A, Phase 1, Moxifloxacin, Placebo, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-54861911-Therapeutic DoseDrug
Also called RSC-385896, MTS-0385896A
JNJ-54861911 50 mg once daily for 7 days in all treatment sequence.
JNJ-54861911 - Supratherapeutic DoseDrug
Also called RSC-385896, MTS-0385896A
JNJ-54861911 150 mg once daily for 7 days in all treatment sequence.
JNJ-54861911-Matched PlaceboDrug
JNJ-54861911-matched placebo once daily for 7 days in all treatment sequence.
MoxifloxacinDrug
Moxifloxacin 400 mg on Day 7 in all treatment sequence.
Moxifloxacin Matched PlaceboDrug
Moxifloxacin matched placebo, 400 mg on Day 7 in all treatment sequence.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: JNJ-54861911-Therapeutic Dose; Drug: JNJ-54861911 - Supratherapeutic Dose; Drug: JNJ-54861911-Matched Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Matched Placebo |
| 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). Receives: Drug: JNJ-54861911-Therapeutic Dose; Drug: JNJ-54861911 - Supratherapeutic Dose; Drug: JNJ-54861911-Matched Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Matched Placebo |
| 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). Receives: Drug: JNJ-54861911-Therapeutic Dose; Drug: JNJ-54861911 - Supratherapeutic Dose; Drug: JNJ-54861911-Matched Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Matched Placebo |
| 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). Receives: Drug: JNJ-54861911-Therapeutic Dose; Drug: JNJ-54861911 - Supratherapeutic Dose; Drug: JNJ-54861911-Matched Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Matched Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in QT/QTc interval at Day 7
Measured: Baseline and Day 7
Secondary outcomes (7)
Change From Baseline in Other Electrocardiogram (ECG) Parameters at Day 7
Other ECG parameters included RR interval, PR interval and QRS interval.
Measured: Baseline and Day 7
Maximum Plasma Concentration (C[max]ss) at Steady State
The C(max)ss is the maximum plasma concentration at steady state which will be observed during dosing interval.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trials, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152332
- Sponsor's protocol ID
- CR104508
- Other IDs
- 54861911ALZ1007
- Status last verified
- Nov 2014
- First submitted
- 29 May 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02152332
- Acronym / sponsor ID
- CR104508
- Conditions
- Healthy
- Keywords
- JNJ-54861912, RSC-385896, MTS-0385896A, Phase 1, Moxifloxacin, Placebo, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence Group ADBC | Experimental | Drug: JNJ-54861911-Therapeutic Dose, Drug: JNJ-54861911 - Supratherapeutic Dose, Drug: JNJ-54861911-Matched Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin Matched PlaceboParticipant 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 BACD | Experimental | Drug: JNJ-54861911-Therapeutic Dose, Drug: JNJ-54861911 - Supratherapeutic Dose, Drug: JNJ-54861911-Matched Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin Matched PlaceboParticipant 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 CBDA | Experimental | Drug: JNJ-54861911-Therapeutic Dose, Drug: JNJ-54861911 - Supratherapeutic Dose, Drug: JNJ-54861911-Matched Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin Matched PlaceboParticipant 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 DCAB | Experimental | Drug: JNJ-54861911-Therapeutic Dose, Drug: JNJ-54861911 - Supratherapeutic Dose, Drug: JNJ-54861911-Matched Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin Matched PlaceboParticipant 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-54861911-Therapeutic DoseAlso: RSC-385896, MTS-0385896AJNJ-54861911 50 mg once daily for 7 days in all treatment sequence. | Drug | Treatment Sequence Group ADBC, Treatment Sequence Group BACD, Treatment Sequence Group CBDA, Treatment Sequence Group DCAB |
| JNJ-54861911 - Supratherapeutic DoseAlso: RSC-385896, MTS-0385896AJNJ-54861911 150 mg once daily for 7 days in all treatment sequence. | Drug | Treatment Sequence Group ADBC, Treatment Sequence Group BACD, Treatment Sequence Group CBDA, Treatment Sequence Group DCAB |
| JNJ-54861911-Matched PlaceboJNJ-54861911-matched placebo once daily for 7 days in all treatment sequence. | Drug | Treatment Sequence Group ADBC, Treatment Sequence Group BACD, Treatment Sequence Group CBDA, Treatment Sequence Group DCAB |
| MoxifloxacinMoxifloxacin 400 mg on Day 7 in all treatment sequence. | Drug | Treatment Sequence Group ADBC, Treatment Sequence Group BACD, Treatment Sequence Group CBDA, Treatment Sequence Group DCAB |
| Moxifloxacin Matched PlaceboMoxifloxacin matched placebo, 400 mg on Day 7 in all treatment sequence. | Drug | Treatment Sequence Group ADBC, Treatment Sequence Group BACD, Treatment Sequence Group CBDA, Treatment Sequence Group DCAB |
Primary outcome
Change From Baseline in QT/QTc interval at Day 7
Time frame: Baseline and Day 7
7 secondary outcomes
Change From Baseline in Other Electrocardiogram (ECG) Parameters at Day 7
Time frame: Baseline and Day 7
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trials study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-54861911-Therapeutic Dose, JNJ-54861911 - Supratherapeutic Dose and Moxifloxacin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in QT/QTc interval at Day 7 (time frame: Baseline and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.