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The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTDS | Experimental | Buprenorphine transdermal patches 10, 40 (2 x 20), and 80 (4 x 20) mcg/hr |
|
| BTDS with naltrexone | Experimental | Buprenorphine transdermal patches 10, 40 (2 x 20), and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets |
|
| Naltrexone | Active Comparator | Naltrexone 50 mg tablets |
|
| Placebo | Placebo Comparator | Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets |
|
| Moxifloxacin | Active Comparator | Moxifloxacin 400-mg tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine transdermal patch | Drug | Buprenorphine patch applied transdermally |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI) | The effects of 10 mcg/hr buprenorphine (Day 6) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 10 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction. | Baseline to Day 6 |
| The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI) | The effects of 40 mcg/hr buprenorphine (Day 13) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 40 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction. | Baseline to Day 13 |
| The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI) | The effects of 80 mcg/hr buprenorphine (Day 17) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 80 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction. |
| Measure | Description | Time Frame |
|---|---|---|
| QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval | Mean change from baseline for the BTDS 10 mcg/hr dose on Day 6, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. | Baseline to Day 6 |
Not provided
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 might interfere with drug absorption (transdermal or gastrointestinal), 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 buprenorphine, any excipient of BTDS, opioids, psychotropic or hypnotic drugs, and/or 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 in this study.
Any significant illness during the 30 days preceding the initial dose 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.
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, ECG, or clinical laboratory values, unless those abnormalities were judged clinically insignificant by the investigator.
Oxygen saturation (SpO2) ≤ 94% as measured by pulse oximetry.
Refusal to abstain from caffeine or xanthine containing beverages entirely during confinement.
Refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration and any time during study.
History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test
Blood or blood products donated within 30 days prior to study drug administration or anytime during the study.
Positive results of urine drug screen or alcohol screen.
Positive results of hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV).
Positive naloxone challenge test.
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.
Subjects who have allergies or other contraindications to transdermal systems or patch adhesives.
Clinically significant history of allergic reaction to wound dressings or elastoplast.
Subjects with a dermatological disorder at any relevant patch application site that precludes proper placement and/or rotation of patch.
Taking antihistamines within 72 hours prior to dosing or systemic or topical corticosteroids within 3 weeks prior to dosing.
Subjects will not allow hair to be removed at the proposed patch application site which may prevent proper placement of the patch.
Subjects for whom a proper assessment of possible application site reactions would be confounded by local skin conditions.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase I Clinic | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27927048 | Result | Harris SC, Morganroth J, Ripa SR, Thorn MD, Colucci S. Effects of buprenorphine on QT intervals in healthy subjects: results of 2 randomized positive- and placebo-controlled trials. Postgrad Med. 2017 Jan;129(1):69-80. doi: 10.1080/00325481.2017.1270156. |
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Healthy adult subjects
First Subject First Visit: 15-March-2012; Last Subject Last Visit: 10-October-2012. The study was conducted at 1 medical/research site in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | BTDS | Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr Buprenorphine transdermal patch: Buprenorphine patch applied transdermally |
| FG001 | BTDS With Naltrexone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Naltrexone tablet | Drug | Naltrexone tablet; 1 tablet taken orally every 12 hours |
|
|
| Placebos (for TDS and for naltrexone and for moxifloxacin) | Drug | Matching placebos |
|
| Moxifloxacin tablet | Drug | Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17 |
|
|
| Baseline to Day 17 |
| Heart Rate (HR) |
Mean change from baseline for the BTDS 10 mcg/hr dose on Day 6, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. |
| Baseline to Day 6 |
| QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval | Mean change from baseline for the BTDS 40 mcg/hr dose on Day 13, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. | Baseline to Day 13 |
| Heart Rate (HR) | Mean change from baseline for the BTDS 40 mcg/hr dose on Day 13, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. | Baseline to Day 13 |
| QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval | Mean change from baseline for the BTDS 80 mcg/hr dose on Day 17, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. | Baseline to Day 17 |
| Heart Rate (HR) | Mean change from baseline for the BTDS 80 mcg/hr dose on Day 17, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. | Baseline to Day 17 |
| ECG Morphology | Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the "new" criterion ("new" meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:
| Baseline to Day 6 |
| ECG Morphology | Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the "new" criterion ("new" meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:
| Baseline to Day 13 |
| ECG Morphology | Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the "new" criterion ("new" meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:
| Baseline to Day 17 |
Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets
Buprenorphine transdermal patch: Buprenorphine patch applied transdermally
Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours
| FG002 | Naltrexone | Naltrexone 50 mg tablets Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours |
| FG003 | Moxifloxacin | Moxifloxacin 400-mg tablets Moxifloxacin tablet: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17 |
| FG004 | Placebo | Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets Placebos (for BTDS and for naltrexone and for moxifloxacin): Matching placebos |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BTDS | Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr Buprenorphine transdermal patch: Buprenorphine patch applied transdermally |
| BG001 | BTDS With Naltrexone | Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets Buprenorphine transdermal patch: Buprenorphine patch applied transdermally Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours |
| BG002 | Naltrexone | Naltrexone 50 mg tablets Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours |
| BG003 | Moxifloxacin | Moxifloxacin 400-mg tablets Moxifloxacin tablet: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17 |
| BG004 | Placebo | Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets Placebos (for TDS and for naltrexone and for moxifloxacin): Matching placebos |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI) | The effects of 10 mcg/hr buprenorphine (Day 6) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 10 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction. | The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. The placebo treatment group is not presented; however, the placebo data were used as a correction factor for these time-matched analyses. | Posted | Mean | 90% Confidence Interval | milliseconds (msec) | Baseline to Day 6 |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI) | The effects of 40 mcg/hr buprenorphine (Day 13) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 40 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction. | The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. The placebo treatment group is not presented; however, the placebo data were used as a correction factor for these time-matched analyses. | Posted | Mean | 90% Confidence Interval | msec | Baseline to Day 13 |
| ||||||||||||||||||||||||||||||||||||
| Primary | The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI) | The effects of 80 mcg/hr buprenorphine (Day 17) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 80 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction. | The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. The placebo treatment group is not presented; however, the placebo data were used as a correction factor for these time-matched analyses. | Posted | Mean | 90% Confidence Interval | msec | Baseline to Day 17 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval | Mean change from baseline for the BTDS 10 mcg/hr dose on Day 6, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. | The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. | Posted | Mean | Standard Deviation | msec | Baseline to Day 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Heart Rate (HR) | Mean change from baseline for the BTDS 10 mcg/hr dose on Day 6, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. | The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. | Posted | Mean | Standard Deviation | bpm | Baseline to Day 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval | Mean change from baseline for the BTDS 40 mcg/hr dose on Day 13, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. | The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. | Posted | Mean | Standard Deviation | msec | Baseline to Day 13 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Heart Rate (HR) | Mean change from baseline for the BTDS 40 mcg/hr dose on Day 13, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. | The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. | Posted | Mean | Standard Deviation | bpm | Baseline to Day 13 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval | Mean change from baseline for the BTDS 80 mcg/hr dose on Day 17, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. | The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. | Posted | Mean | Standard Deviation | msec | Baseline to Day 17 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Heart Rate (HR) | Mean change from baseline for the BTDS 80 mcg/hr dose on Day 17, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo. | The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. | Posted | Mean | Standard Deviation | bpm | Baseline to Day 17 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | ECG Morphology | Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the "new" criterion ("new" meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:
| The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. | Posted | Count of Participants | Participants | Baseline to Day 6 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | ECG Morphology | Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the "new" criterion ("new" meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:
| The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. | Posted | Count of Participants | Participants | Baseline to Day 13 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | ECG Morphology | Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the "new" criterion ("new" meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:
| The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG. | Posted | Count of Participants | Participants | Baseline to Day 17 |
|
Adverse events (AEs) and serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion; AEs were reported through 7 days and SAEs through 30 days after last study drug dose, or until last study visit, whichever was later.
AEs were learned of through spontaneous reports or subject interview.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BTDS | Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr Buprenorphine transdermal patch: Buprenorphine patch applied transdermally | 1 | 66 | 59 | 66 | ||
| EG001 | BTDS With Naltrexone | Buprenorphine transdermal patches 10, 40 (2 x 20) and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets Buprenorphine transdermal patch: Buprenorphine patch applied transdermally Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours | 0 | 66 | 47 | 66 | ||
| EG002 | Naltrexone | Naltrexone 50 mg tablets Naltrexone tablet: Naltrexone tablet; 1 tablet taken orally every 12 hours | 0 | 66 | 49 | 66 | ||
| EG003 | Moxifloxacin | Moxifloxacin 400-mg tablets Moxifloxacin tablet: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17 | 0 | 65 | 37 | 65 | ||
| EG004 | Placebo | Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets Placebos (for TDS and for naltrexone and for moxifloxacin): Matching placebos | 0 | 65 | 34 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infrequent bowel movements | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment | Onset of event occurred before study drug administration. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Infrequent bowel movements | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Application site papules | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Application site rash | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Feeling drunk | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Application site pustules | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Purdue Pharma L.P. | 800-733-1333 | stephen.harris@pharma.com |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009271 | Naltrexone |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009270 | Naloxone |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Naltrexone Alone (Placebo-corrected ΔΔQTcI) |
Naltrexone 50 mg tablets |
| OG003 | Moxifloxacin (Placebo-corrected ΔΔQTcI) | Moxifoxacin 400 mg tablet (positive control) |
|
|
| Naltrexone Alone (Placebo-corrected ΔΔQTcI) |
Naltrexone 50 mg tablets |
| OG003 | Moxifloxacin (Placebo-corrected ΔΔQTcI) | Moxifloxacin 400 mg tablet (positive control) |
|
|
| Placebo |
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets |
|
|
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets |
|
|
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets |
|
|
Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets
|
|
| Naltrexone Alone |
Naltrexone 50 mg tablets |
| OG003 | Moxifloxacin | Moxifloxacin 400 mg tablet (positive control) |
| OG004 | Placebo | Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets |
|
|
| Naltrexone Alone |
Naltrexone 50 mg tablets |
| OG003 | Moxifloxacin | Moxifloxacin 400 mg tablet (positive control) |
| OG004 | Placebo | Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets |
|
|
| Naltrexone Alone |
Naltrexone 50 mg tablets |
| OG003 | Moxifloxacin | Moxifloxacin 400 mg tablet (positive control) |
| OG004 | Placebo | Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets |
|
|