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Evaluate the effect of multiple doses (once daily for 3 days each of HYD 80, 120, and 160 mg tablets) on the QT/QTc interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HYD | Experimental |
| |
| Moxifloxacin | Other | Moxifloxacin is the positive control. |
|
| Placebo | Placebo Comparator | Placebo for HYD and placebo for moxifloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HYD | Drug | Hydrocodone bitartrate 80 mg (day 9), 120 mg (day 12), 160 mg [(1) 40 mg tablet + (1) 120 mg tablet] (day 15) extended-release tablets administered orally every 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method | The electrocardiogram (ECG) effects of HYD 80 mg (day 9) on the QT/QTc interval | Baseline and Day 9 |
| The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method | The ECG effects of HYD 120 mg (day 12) on the QT/QTc interval | Baseline and Day 12 |
| The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method | The ECG effects of HYD 160 mg (day 15) on the QT/QTc interval | Baseline and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method | The ECG effects of moxifloxacin (day 9) on the QT/QTc interval | Baseline and Day 9 |
| The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method |
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Inclusion Criteria:
Exclusion Criteria:
Females who are pregnant (positive beta human chorionic gonadotropin test) or lactating;
Current or recent (within 5 years) history of drug or alcohol abuse;
History or any current conditions that may interfere with drug absorption, distribution, metabolism, or excretion;
Use of an opioid-containing medication in the past 30 days preceding the initial dose in this study;
Known allergy to hydrocodone, opioids, psychotropic or hypnotic drugs, moxifloxacin, or any member of the quinolone class drugs;
Any history of frequent nausea or emesis regardless of etiology;
Any history of seizures or head trauma with sequelae;
Participation in a clinical drug study during the 30 days preceding the initial dose of study drug in this study;
Use of any medication including thyroid hormonal therapy (hormonal contraception and hormonal replacement therapy in the form of estrogen with or without progestin is allowed), vitamins, herbal and/or mineral supplements during the 7 days preceding the initial dose of study drug;
Any significant illness during the 30 days preceding the initial dose of study drug in this study;
Any personal or family history of prolonged QT interval or disorders of cardiac rhythm;
Abnormal cardiac conditions including hypertension;
Abnormal cardiac condition denoted by any of the following:
Abnormalities on physical examination, vital signs, safety 12-lead ECG, or clinical laboratory values, unless those abnormalities are judged clinically insignificant by the investigator;
Oxygen saturation <94% as measured by pulse oximetry (SpO2);
Refusal to abstain completely from caffeine or xanthine during confinement;
Refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration through the end-of-study visit;
Blood or blood products donated within 30 days prior to initial study drug administration or any time through the end-of-study visit, except as required by the study protocol;
History of smoking or use of nicotine products within 45 days of initial study drug administration or a positive urine cotinine test;
Positive results of urine drug screen or alcohol screen;
Positive results of hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV);
Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities;
The investigator believes the subject to be unsuitable for reason(s) not specifically stated in the exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase I Clinic | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin | Drug | Moxifloxacin 400 mg tablets administered orally on the morning of day 9, day 12, and day 15 only. |
|
|
| Placebo for HYD | Drug | Placebo to match HYD tablets administered orally every 24 hours. |
|
| Placebo for moxifloxacin | Drug | Placebo to match moxifloxacin tablets administered orally on the mornings of day 9, day 12, and day 15 only. |
|
The ECG effects of moxifloxacin (day 12) on the QT/QTc interval |
| Baseline and Day 12 |
| The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method | The ECG effects of moxifloxacin (day 15) on the QT/QTc interval | Baseline and Day 15 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |