A Phase 1 interventional study of Tramadol HCl and Moxifloxacin 400 mg in Healthy, sponsored by Janssen Scientific Affairs, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by Janssen Scientific Affairs, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the effects of multiple doses of an immediate release (IR) formulation of tramadol hydrochloride (HCl) at therapeutic and supratherapeutic levels in healthy adult participants on the electrocardiogram (ECG) QT interval corrected for heart rate (QTc).
This is a randomized (study medication assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), 4-way crossover (method used to switch participants from one treatment arm to another), placebo- and positive-controlled (the experimental treatment or procedure is compared to an inactive substance and a standard treatment or procedure), single site, multiple dose study. The study has 3 phases: a Screening Phase (up to 35 days); a Double-blind Treatment Phase (4 treatment periods with a washout period of 7 to 15 days); and a Post-treatment Phase (Day 5 of Period 4 or at the time of early withdrawal). All eligible participants will receive each of the 4 treatments: tramadol HCl at therapeutic dose of 400 milligram per day (mg/day), tramadol HCl at supratherapeutic dose of 600 mg/day, placebo, and positive control moxifloxacin 400 mg; in any of the treatment period as per assigned treatment sequence. The total duration of each participant's participation will be up to a maximum of 100 days. Participants' safety will be monitored throughout the study.
Janssen Scientific Affairs, LLC is the lead sponsor of 41 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
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Exclusion Criteria:
Participants will receive treatment A (2\*50 milligram \[mg\] tramadol hydrochloride \[HCl\] immediate release \[IR\] tablet + 1 tramadol HCl placebo every 6 hours on Days 1, 2, and 3, along with single dose of 2\*50 mg tramadol HCl IR tablet + 1 tramadol HCl placebo + 1 moxifloxacin placebo on Day 4); treatment B (3\*50 mg tramadol HCl IR tablet every 6 hours on Days 1, 2, and 3, along with single dose of 3\*50 mg tramadol HCl IR tablet + 1 moxifloxacin placebo on Day 4); treatment C (3 tramadol HCl placebo every 6 hours on Days 1, 2, and 3, along with single dose of 3 tramadol HCl placebo + 1 moxifloxacin placebo on Day 4); and treatment D (3 tramadol HCl placebo every 6 hours on Days 1, 2, and 3, along with single dose of 3 tramadol HCl placebo + 1 moxifloxacin placebo on Day 4) in 4 treatment periods as per protocol defined sequence. A washout period of 7 to 15 days will be maintained between each treatment period.
Drug: Tramadol HCl · Drug: Moxifloxacin 400 mg · Drug: Tramadol HCl Placebo · Drug: Moxifloxacin Placebo
Participants will receive treatment A; treatment B; treatment C; and treatment D in 4 treatment periods as per protocol defined sequence. A washout period of 7 to 15 days will be maintained between each treatment period.
Drug: Tramadol HCl · Drug: Moxifloxacin 400 mg · Drug: Tramadol HCl Placebo · Drug: Moxifloxacin Placebo
Participants will receive treatment A; treatment B; treatment C; and treatment D in 4 treatment periods as per protocol defined sequence. A washout period of 7 to 15 days will be maintained between each treatment period.
Drug: Tramadol HCl · Drug: Moxifloxacin 400 mg · Drug: Tramadol HCl Placebo · Drug: Moxifloxacin Placebo
Participants will receive treatment A; treatment B; treatment C; and treatment D in 4 treatment periods as per protocol defined sequence. A washout period of 7 to 15 days will be maintained between each treatment period.
Drug: Tramadol HCl · Drug: Moxifloxacin 400 mg · Drug: Tramadol HCl Placebo · Drug: Moxifloxacin Placebo
Tramadol HCl 50 mg immediate release (IR) tablet administered orally.
Also known as: RWJ-26898-002
Moxifloxacin 400 mg tablet administered orally.
Also known as: Avelox
Placebo matched to tramadol HCl IR tablet administered orally.
Placebo matched to Moxifloxacin 400 mg tablet administered orally.
Change From Baseline in QTc Interval
The QT interval corrected for heart rate (QTc interval) using Fridericia, Bazett and study-specific power correction methods, will be measured by electrocardiograms (ECG).
Time frame: Baseline (pre-dose, Day1); pre-dose up to 24 hours post-dose on Day 4
Change From Baseline in HR, QRS, and PR Intervals
The HR, QRS, and PR Intervals, will be measured by ECG.
Time frame: Baseline (pre-dose, Day1); pre-dose up to 24 hours post-dose on Day 4
Number of Participants with T-wave and U-wave Morphological Changes
The number of participants having T wave morphology changes from baseline and/or the occurrence of abnormal U-waves that represent the appearance or worsening of the morphological abnormality will be reported.
Time frame: Baseline (pre-dose, Day1); pre-dose up to 24 hours post-dose on Day 4
Maximum Plasma Concentration During a Dosing Interval at Steady State (Cmax,ss)
The Cmax,ss is the maximum plasma concentration at steady state which will be observed during a dosing interval.
Time frame: Pre-dose up to 24 hours post-dose on Day 4
Trough Plasma Concentration Before Dosing (pre-dose) At Steady State (Ctrough,ss)
The Ctrough,ss refers to the drug concentration at steady state, at the time when it is expected to reach its minimum (trough) concentration.
Time frame: Pre-dose up to 24 hours post-dose on Day 4
Time to Reach the Maximum Plasma Concentration at Steady State (Tmax,ss)
The Tmax,ss is the time to reach maximum plasma concentration at steady state which will be observed during a dosing interval.
Time frame: Pre-dose up to 24 hours post-dose on Day 4
Area Under the Plasma Concentration-Time Curve During a Dosing Interval (tau) at Steady State (AUCtau,ss)
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.
Time frame: Pre-dose up to 24 hours post-dose on Day 4
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Screening up to end of study (30 days after the last dose of study drug or early withdrawal)
Ran from Dec 2014 to primary completion in Aug 2015, 8 months.
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tramadol
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