HealthyPhase 1NCT02243241
The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects
A Phase 1 study testing HYD and Moxifloxacin in people with Healthy, run by Purdue Pharma LP at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HYD and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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;
- The investigator believes the subject to be unsuitable for reason(s) not specifically stated in the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo- and Positive-Controlled, Parallel Group, Dose Escalating Study of the Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets at Doses up to 160 mg on QT/QTc in Healthy Adult Subjects
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
- Being tested
- HYD, Moxifloxacin, Placebo for HYD, Placebo for moxifloxacin
- Keywords
- Healthy volunteers, Opioid, ECG, QTcI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYDDrug
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.
MoxifloxacinDrug
Also called Avelox®
Moxifloxacin 400 mg tablets administered orally on the morning of day 9, day 12, and day 15 only.
Placebo for HYDDrug
Placebo to match HYD tablets administered orally every 24 hours.
Placebo for moxifloxacinDrug
Placebo to match moxifloxacin tablets administered orally on the mornings of day 9, day 12, and day 15 only.
| Study group | Role | What they receive |
|---|---|---|
| HYD | Experimental | Not described Receives: Drug: HYD; Drug: Placebo for moxifloxacin |
| Moxifloxacin | Other | Moxifloxacin is the positive control. Receives: Drug: Moxifloxacin; Drug: Placebo for HYD |
| Placebo | Placebo comparator | Placebo for HYD and placebo for moxifloxacin Receives: Drug: Placebo for HYD; Drug: Placebo for moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
The ECG effects of moxifloxacin (day 9) on the QT/QTc interval
Measured: 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 moxifloxacin (day 12) on the QT/QTc interval
Measured: 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
Measured: Baseline and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243241
- Sponsor's protocol ID
- HYD1009
- Status last verified
- Sep 2014
- First submitted
- 15 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo- and Positive-Controlled, Parallel Group, Dose Escalating Study of the Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets at Doses up to 160 mg on QT/QTc in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02243241
- Acronym / sponsor ID
- HYD1009
- Conditions
- Healthy
- Keywords
- Healthy volunteers, Opioid, ECG, QTcI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HYD | Experimental | Drug: HYD, Drug: Placebo for moxifloxacin |
| Moxifloxacin | Other | Drug: Moxifloxacin, Drug: Placebo for HYDMoxifloxacin is the positive control. |
| Placebo | Placebo comparator | Drug: Placebo for HYD, Drug: Placebo for moxifloxacinPlacebo for HYD and placebo for moxifloxacin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (29 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HYDHydrocodone 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. | Drug | HYD |
| MoxifloxacinAlso: Avelox®Moxifloxacin 400 mg tablets administered orally on the morning of day 9, day 12, and day 15 only. | Drug | Moxifloxacin |
| Placebo for HYDPlacebo to match HYD tablets administered orally every 24 hours. | Drug | Moxifloxacin, Placebo |
| Placebo for moxifloxacinPlacebo to match moxifloxacin tablets administered orally on the mornings of day 9, day 12, and day 15 only. | Drug | HYD, Placebo |
Primary outcome
The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method
Time frame: Baseline and Day 9
The electrocardiogram (ECG) effects of HYD 80 mg (day 9) on the QT/QTc interval
The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method
Time frame: Baseline and Day 12
The ECG effects of HYD 120 mg (day 12) on the QT/QTc interval
The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method
Time frame: Baseline and Day 15
The ECG effects of HYD 160 mg (day 15) on the QT/QTc interval
3 secondary outcomes
The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method
Time frame: 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
Time frame: 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
Time frame: Baseline and Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HYD and Moxifloxacin in people with Healthy, run by Purdue Pharma LP at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method (time frame: Baseline and Day 9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.