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

NCT ID: NCT02243241

Last Updated: 2014-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-05-31

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

HYD

Group Type: EXPERIMENTAL

HYD

Intervention Type: 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.

Placebo for moxifloxacin

Intervention Type: DRUG

Placebo to match moxifloxacin tablets administered orally on the mornings of day 9, day 12, and day 15 only.

Moxifloxacin

Moxifloxacin is the positive control.

Group Type: OTHER

Moxifloxacin

Intervention Type: DRUG

Moxifloxacin 400 mg tablets administered orally on the morning of day 9, day 12, and day 15 only.

Placebo for HYD

Intervention Type: DRUG

Placebo to match HYD tablets administered orally every 24 hours.

Placebo

Placebo for HYD and placebo for moxifloxacin

Group Type: PLACEBO_COMPARATOR

Placebo for HYD

Intervention Type: DRUG

Placebo to match HYD tablets administered orally every 24 hours.

Placebo for moxifloxacin

Intervention Type: DRUG

Placebo to match moxifloxacin tablets administered orally on the mornings of day 9, day 12, and day 15 only.

Interventions

HYD

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.

Intervention Type: DRUG

Moxifloxacin

Moxifloxacin 400 mg tablets administered orally on the morning of day 9, day 12, and day 15 only.

Intervention Type: DRUG

Placebo for HYD

Placebo to match HYD tablets administered orally every 24 hours.

Intervention Type: DRUG

Placebo for moxifloxacin

Placebo to match moxifloxacin tablets administered orally on the mornings of day 9, day 12, and day 15 only.

Intervention Type: DRUG

Other Intervention Names

Avelox®

Eligibility Criteria

Inclusion Criteria

• 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).

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:

• 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;
• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PPD Phase I Clinic

Austin, Texas, United States

Countries

United States

Other Identifiers

HYD1009

Identifier Type: -

Identifier Source: org_study_id