The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02243241

Run by

Purdue Pharma LP

People needed

208

Starts

2012-11-01

Expected to finish

2013-05-01

Last updated by the study team

2014-09-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provide written informed consent;
• Body weight ranging from 50 to 100 kilograms (kg) [110 to 220 pounds] and body mass index (BMI) of 18 to 30 (kg/m2);
• Males and females aged 18 to 50 years;
• Willing to eat the food supplied during the study;
• Willing to refrain from strenuous exercise through the end-of-study visit. Subjects did not begin a new exercise program nor participate in any unusually strenuous physical exertion;
• Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and safety 12-lead ECG;
• Females of childbearing potential must use an adequate and reliable method of contraception (ie, barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception). Females who are postmenopausal must be postmenopausal for ≥ 1 year and have elevated serum follicle stimulating hormone (FSH).

You may not qualify if…

• 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:
• QT data corrected for heart rate using the Fridericia formula (QTcF) interval >450 milliseconds (msec)
• PR interval >240 msec or QRS >110 msec
• Evidence of second- or third-degree atrioventricular block
• Pathological Q-waves (defined as Q-wave >40 msec or depth >0.5 millivolts [mV])
• Evidence of ventricular pre-excitation, complete left bundle branch block (LBBB), right bundle branch block (RBBB), or incomplete RBBB
• With a resting heart rate (HR) outside the range of 40 to 90 beats per minute (bpm);
• 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;

Where it is running

• PPD Phase I Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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