A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants
NCT ID: NCT02737605
Last Updated: 2018-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
62 participants
INTERVENTIONAL
2016-07-01
2017-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Sequence 1
Participants will receive Treatment A (intravenous placebo, Intranasal placebo and Oral placebo tablet matched to the moxifloxacin tablet) on Day 1 of period 1, Treatment B (intravenous placebo, 84 milligram (mg) of intranasal esketamine and Oral placebo tablet matched to the moxifloxacin tablet) on Day 1 of period 2, Treatment C (intravenous placebo, Intranasal placebo and 400 mg oral moxifloxacin tablet) on Day 1 of period 3, Treatment D (0.8 milligram per kilogram of intravenous esketamine, Intranasal placebo and Oral placebo tablet matched to the moxifloxacin tablet ) on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 5 to 7 days.
Intranasal Esketamine
Participants will receive 84 mg intranasal esketamine as 3 devices, each with 28 mg esketamine.
Intravenous Esketamine
Participants will receive 0.8 milligram per kilogram body weight esketamine, 40 minutes, intravenous infusion.
Moxifloxacin
Participants will receive 400 mg Moxifloxacin orally.
Oral Placebo
Participants will receive matching placebo orally.
Intravenous Placebo
Participants will receive placebo 40 minutes, intravenous infusion.
Intranasal Placebo
Participants will receive intranasal placebo (1 spray in each nostril at 0, 5, and 10 minutes).
Sequence 2
Participants will receive Treatment A on Day 1 of period 1, Treatment C on Day 1 of period 2, Treatment B on Day 1 of period 3, Treatment D on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 5 to 7 days.
Intranasal Esketamine
Participants will receive 84 mg intranasal esketamine as 3 devices, each with 28 mg esketamine.
Intravenous Esketamine
Participants will receive 0.8 milligram per kilogram body weight esketamine, 40 minutes, intravenous infusion.
Moxifloxacin
Participants will receive 400 mg Moxifloxacin orally.
Oral Placebo
Participants will receive matching placebo orally.
Intravenous Placebo
Participants will receive placebo 40 minutes, intravenous infusion.
Intranasal Placebo
Participants will receive intranasal placebo (1 spray in each nostril at 0, 5, and 10 minutes).
Sequence 3
Participants will receive Treatment B on Day 1 of period 1, Treatment C on Day 1 of period 2, Treatment A on Day 1 of period 3, Treatment D on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 5 to 7 days.
Intranasal Esketamine
Participants will receive 84 mg intranasal esketamine as 3 devices, each with 28 mg esketamine.
Intravenous Esketamine
Participants will receive 0.8 milligram per kilogram body weight esketamine, 40 minutes, intravenous infusion.
Moxifloxacin
Participants will receive 400 mg Moxifloxacin orally.
Oral Placebo
Participants will receive matching placebo orally.
Intravenous Placebo
Participants will receive placebo 40 minutes, intravenous infusion.
Intranasal Placebo
Participants will receive intranasal placebo (1 spray in each nostril at 0, 5, and 10 minutes).
Sequence 4
Participants will receive Treatment B on Day 1 of period 1, Treatment A on Day 1 of period 2, Treatment C on Day 1 of period 3, Treatment D on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 5 to 7 days.
Intranasal Esketamine
Participants will receive 84 mg intranasal esketamine as 3 devices, each with 28 mg esketamine.
Intravenous Esketamine
Participants will receive 0.8 milligram per kilogram body weight esketamine, 40 minutes, intravenous infusion.
Moxifloxacin
Participants will receive 400 mg Moxifloxacin orally.
Oral Placebo
Participants will receive matching placebo orally.
Intravenous Placebo
Participants will receive placebo 40 minutes, intravenous infusion.
Intranasal Placebo
Participants will receive intranasal placebo (1 spray in each nostril at 0, 5, and 10 minutes).
Sequence 5
Participants will receive Treatment C on Day 1 of period 1, Treatment A on Day 1 of period 2, Treatment B on Day 1 of period 3, Treatment D on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 5 to 7 days.
Intranasal Esketamine
Participants will receive 84 mg intranasal esketamine as 3 devices, each with 28 mg esketamine.
Intravenous Esketamine
Participants will receive 0.8 milligram per kilogram body weight esketamine, 40 minutes, intravenous infusion.
Moxifloxacin
Participants will receive 400 mg Moxifloxacin orally.
Oral Placebo
Participants will receive matching placebo orally.
Intravenous Placebo
Participants will receive placebo 40 minutes, intravenous infusion.
Intranasal Placebo
Participants will receive intranasal placebo (1 spray in each nostril at 0, 5, and 10 minutes).
Sequence 6
Participants will receive Treatment C on Day 1 of period 1, Treatment B on Day 1 of period 2, Treatment A on Day 1 of period 3, Treatment D on Day 1 of period 4. Periods 1, 2, 3 and 4 will be separated by 5 to 7 days.
Intranasal Esketamine
Participants will receive 84 mg intranasal esketamine as 3 devices, each with 28 mg esketamine.
Intravenous Esketamine
Participants will receive 0.8 milligram per kilogram body weight esketamine, 40 minutes, intravenous infusion.
Moxifloxacin
Participants will receive 400 mg Moxifloxacin orally.
Oral Placebo
Participants will receive matching placebo orally.
Intravenous Placebo
Participants will receive placebo 40 minutes, intravenous infusion.
Intranasal Placebo
Participants will receive intranasal placebo (1 spray in each nostril at 0, 5, and 10 minutes).
Interventions
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Intranasal Esketamine
Participants will receive 84 mg intranasal esketamine as 3 devices, each with 28 mg esketamine.
Intravenous Esketamine
Participants will receive 0.8 milligram per kilogram body weight esketamine, 40 minutes, intravenous infusion.
Moxifloxacin
Participants will receive 400 mg Moxifloxacin orally.
Oral Placebo
Participants will receive matching placebo orally.
Intravenous Placebo
Participants will receive placebo 40 minutes, intravenous infusion.
Intranasal Placebo
Participants will receive intranasal placebo (1 spray in each nostril at 0, 5, and 10 minutes).
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 18 and 30 kilogram (kg)/meter square (\[m\]\^2) (inclusive), and body weight not less than 50 kilogram (kg)
* Women using oral contraceptives must agree to use an additional birth control method during the study and for 1 month after receiving the last dose of study drug or until after the next menstrual period
* A woman of child-bearing potential, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test on Day -1 of the first treatment period
* A man, must agree to use an adequate contraception method as deemed appropriate by the investigator (example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
Exclusion Criteria
* Clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, gastrointestinal disease, hypertension, vascular disorders, sleep apnea, myasthenia gravis, or any other illness that the investigator considers should exclude the participant 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, 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)
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at Screening or at admission to the study center for the first treatment period as deemed appropriate by the investigator. Electrolytes (potassium, magnesium, calcium) should be within the reference range of the laboratory
* Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at Screening or at admission to the study center for the first treatment period as deemed appropriate by the investigator
18 Years
55 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Berlin, , Germany
Countries
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Other Identifiers
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2014-004457-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ESKETINTRD1013
Identifier Type: OTHER
Identifier Source: secondary_id
CR106218
Identifier Type: -
Identifier Source: org_study_id
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