Study S003233

A Randomized, Double-Blind, Parallel, Nested Crossover Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)

ClinicalTrials.gov record

Registration

Registration: NCT03606057
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 188
Start: 2018-07-13
Primary completion: 2019-02-08
Lead sponsor: Janssen Research & Development, LLC
Conditions: Healthy
Interventions: DRUG:JNJ-64565111; DRUG:Moxifloxacin; DRUG:JNJ-64565111-matching Placebo; DRUG:Moxifloxacin-matching Placebo
Results posted: FALSE
Secondary identifiers: OTHER:64565111OBE1002

Registered primary outcomes

Placebo-Corrected Change from Baseline in QT Interval Corrected for Individual Heart Rate (QTcI) on Day 26 Time-Matched Time Points [Baseline and Day 26]
Change from Time-Matched Baseline in QTc Interval [Up to Day 27]
Change from Time-Matched Baseline in Heart Rate (HR) [Up to Day 27]
Change from Time-Matched Baseline in QRS Interval [Up to Day 27]
Change from Time-Matched Baseline in PR Interval [Up to Day 27]

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