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

NCT02243241 | Completed Phase 1

• 1 other identifier: HYD1009
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy volunteers; Opioid; ECG; QTcI

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method

  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

  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

  Baseline and Day 15

Study Arms (3)

HYD

EXPERIMENTAL

Drug: HYD; Drug: Placebo for moxifloxacin

Moxifloxacin

OTHER

Moxifloxacin is the positive control.

Drug: Moxifloxacin; Drug: Placebo for HYD

Placebo

PLACEBO COMPARATOR

Placebo for HYD and placebo for moxifloxacin

Drug: Placebo for HYD; Drug: Placebo for moxifloxacin

Interventions

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.

HYD

Moxifloxacin DRUG

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

Also known as: Avelox®

Moxifloxacin

Placebo for HYD DRUG

Placebo to match HYD tablets administered orally every 24 hours.

Moxifloxacin; Placebo

Placebo for moxifloxacin DRUG

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

HYD; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (1)

PPD Phase I Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 17, 2014
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

US (1)