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

NCT02152332 | Completed Phase 1

• 2 other identifiers: CR10450854861911ALZ1007
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

JNJ-54861912; RSC-385896; MTS-0385896A; Phase 1; Moxifloxacin; Placebo; Healthy

Outcome Measures

Primary Outcomes (1)

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

  Baseline and Day 7

Secondary Outcomes (7)

• 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

• Trough Plasma Concentration (C[trough])

  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])

  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

Study Arms (4)

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).

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).

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).

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).

Drug: JNJ-54861911-Therapeutic Dose; Drug: JNJ-54861911 - Supratherapeutic Dose; Drug: JNJ-54861911-Matched Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Matched Placebo

Interventions

JNJ-54861911-Therapeutic Dose DRUG

JNJ-54861911 50 mg once daily for 7 days in all treatment sequence.

Also known as: RSC-385896, MTS-0385896A

Treatment Sequence Group ADBC; Treatment Sequence Group BACD; Treatment Sequence Group CBDA; Treatment Sequence Group DCAB

JNJ-54861911 - Supratherapeutic Dose DRUG

JNJ-54861911 150 mg once daily for 7 days in all treatment sequence.

Also known as: RSC-385896, MTS-0385896A

Treatment Sequence Group ADBC; Treatment Sequence Group BACD; Treatment Sequence Group CBDA; Treatment Sequence Group DCAB

JNJ-54861911-Matched Placebo DRUG

JNJ-54861911-matched placebo once daily for 7 days in all treatment sequence.

Treatment Sequence Group ADBC; Treatment Sequence Group BACD; Treatment Sequence Group CBDA; Treatment Sequence Group DCAB

Moxifloxacin DRUG

Moxifloxacin 400 mg on Day 7 in all treatment sequence.

Treatment Sequence Group ADBC; Treatment Sequence Group BACD; Treatment Sequence Group CBDA; Treatment Sequence Group DCAB

Moxifloxacin Matched Placebo DRUG

Moxifloxacin matched placebo, 400 mg on Day 7 in all treatment sequence.

Treatment Sequence Group ADBC; Treatment Sequence Group BACD; Treatment Sequence Group CBDA; Treatment Sequence Group DCAB

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Tempe, Arizona, United States

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trials

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 2, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

US (1)