Restless Legs SyndromePhase 1NCT01516372
A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy Volunteers
A Phase 1 study testing GEn 1200mg, Gen 6000 mg and Moxifloxacin in people with Restless Legs Syndrome, run by XenoPort, Inc. at 1 site in United States.
Trial summary
This will be a randomized, double-blind, placebo- controlled cross-over study to investigate the effect of GEn on cardiac repolarisation parameters compared with placebo and a positive control, moxifloxacin. Approximately 52 subjects will be recruited to the study and will take part in four dosing sessions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- GEn 1200mg, Gen 6000 mg and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Mar 2012
- 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
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
- Male or female between 18 and 50 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and estradiol less than 40 pg/ml (less than 147 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit is completed.
- Body weight greater than and equal to 50 kg and BMI within the range 19 - 30 kg/m2 (inclusive)
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- Creatinine clearance (CrCl) greater than and equal to 80 mL/min. CrCl is estimated using the equation of Cockcroft and Gault. See study procedure manual for details on creatinine clearance calculations.
- AST, ALT, alkaline phosphatase and bilirubin less than and equal to 1.5xULN (isolated bilirubin greater than and equal to 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).
Who cannot join
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for HIV antibody.
- Has cardiac conduction abnormalities on the screening 12-lead ECG denoted by any of the following: QTcB or QTcF interval greater than 450 msec; PR interval greater than 200 msec or less than and equal to 110 msec; Evidence of second- or third- degree atrioventricular block (AVB); Pathological Q-waves (defined as Q-wave greater than 40 msec or depth greater than 0.4- 0.5mV); Evidence of ventricular pre-excitation; Electrocardiographic evidence of complete left bundle branch block (LBBB), right bundle branch block (RBBB), incomplete LBBB; Intraventricular conduction delay with QRS duration greater than 120 msec
- The subject has a screening heart rate less than 50 or greater than 100 bpm or a systolic blood pressure greater than 140 or less than 100 mmHg or a diastolic blood pressure greater than 90 or ;ess than 60 mmHg in the semisupine position
- Subjects with a personal or family history of QTc prolongation, symptomatic cardiac arrhythmias or cardiac arrest
Show all 19Show fewer
- Serum calcium, magnesium or potassium levels outside the reference range
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 14 drinks/week for men or greater than 7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Hormone replacement therapy and contraceptive medication will be allowed in this study.
- History of sensitivity to quinolone antibiotics, gabapentin, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Lactating females or pregnant females as determined by positive serum hCG test at screening or prior to dosing.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
- History of seizures other than febrile seizures as a child.
- Subjects with a creatine kinase (CK) value of greater than the upper limit of normal that is not explainable by recent strenuous exercise and the value does not return within normal range upon retest.
- Has active suicidal plan/intent or has had active suicidal thoughts in the past 6 months. Has history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt.
- Subject is mentally or legally incapacitated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Single Dose Crossover Study to Assess the Effect of Gabapentin Enacarbil on Cardiac Conduction as Compared With Placebo and Moxifloxacin in Healthy Volunteers
This will be a randomized, double-blind, placebo- controlled cross-over study to investigate the effect of GEn on cardiac repolarisation parameters compared with placebo and a positive control, moxifloxacin. Approximately 52 subjects will be recruited to the study and will take part in four dosing sessions. Subjects will receive, in a randomized order, a single dose of 1200 mg GEn, 6000 mg GEn (supratherapeutic dose), 400 mg moxifloxacin (positive control) and placebo. Twelve lead continuous ECG monitoring will be conducted from pre-dose to approximately 24 hours after dosing on Day 1 of each study session. The primary comparison of interest will be the mean change from baseline in the time-matched differences in QTcF between each GEn treatment and placebo.
Read the detailed description
This is a 4-period, randomized, active-and placebo-controlled, double-dummy, double-blind cross-over study to evaluate the effect of single doses of GEn on cardiac conduction parameters in healthy subjects.
Screening will occur within approximately 28 days of the first scheduled dose of study medication. Each subject will participate in 4 dosing sessions at least one week apart. Prior to dosing in each period, the investigator will review the scheduled assessments to confirm the subject's suitability for the study including review of study entry criteria and lifestyle restrictions.
All subjects will receive single doses of GEn 1200 mg, GEn 6000 mg, moxifloxacin 400 mg and placebo in a randomized sequence.
Dosing with moxifloxacin will be in the fasted state and GEn will be administered following a standard meal. A double dummy approach will be used to maintain blinding. Thus, on each dosing day, moxifloxacin or moxifloxacin placebo will be administered in the fasted state in the morning and GEn or matched placebo will be administered 2 hours later after a standard meal.
During each treatment period, subjects will report to the clinical research unit the day before dosing (Day 1) and will remain until completion of the last assessment on Day 2. Twelve-lead ECGs including continuous Holter monitoring, clinical laboratory safety tests, vital sign measurements, physical examinations, adverse event reports, and pharmacokinetic samples will be collected throughout the study.
In each study period, cardiac conduction will be measured using a 24-hour continuous 12-lead Holter monitor from the morning of Day 1 until the morning of Day 2. Extraction of the Holter monitor data in triplicate for analysis will begin on Day 1 at timepoints indicated in the Time and Events Table (Section 4.7). These timepoints were selected to cover the Cmax of both moxifloxacin and GEn. If no clinically significant abnormalities are noted, subjects will be discharged from the clinical research unit after the completion of all assessments on Day 2 in each period. A minimum 7-day washout period will separate each treatment period. A follow-up visit will be conducted approximately 7 to 14 days after administration of the last dose of study medication in treatment period 4
- Conditions
- Restless Legs Syndrome
- Being tested
- GEn 1200mg, Gen 6000 mg, GEn Placebo, Moxifloxacin Placebo, Moxifloxacin
- Keywords
- GEn, moxifloxacin, cardiac repolarisation, QT/QTc
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEn 1200mgDrug
Also called gen1200
1200 mg of Gen administered as a single dose
Gen 6000 mgDrug
Also called gen6000
6000 mg of Gen administered as a single dose
GEn PlaceboDrug
Placebo to match GEn Tablets
Moxifloxacin PlaceboDrug
Placebo to match Moxifloxacin
MoxifloxacinDrug
Also called moxifloxacin 400
400 mg Moxifloxacin administered as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Healthy Volunteers will receive Treatments ABDC Receives: Drug: GEn 1200mg; Drug: Moxifloxacin Placebo |
| Treatment 2 | Experimental | Healthy Volunteers will receive Treatments BCAD Receives: Drug: Gen 6000 mg; Drug: Moxifloxacin Placebo |
| Treatment 3 | Experimental | Healthy Volunteers will receive Treatments CDBA Receives: Drug: GEn Placebo |
| Treatment 4 | Experimental | Healthy Volunteers will receive Treatments DACB Receives: Drug: GEn Placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QTcF (QT duration corrected for heart rate by Fridericia's formula) interval at Each time point for 6000 mg GEn and Placebo measured by ECG
Measured: Day -1-Day2
Secondary outcomes (7)
Change in QTcF interval at Each time point for 1200 mg GEn and Placebo measured by ECG
Measured: Day -1-Day 2
Change from baseline in QTcF interval at each time point for moxifloxacin 400 mg and placebo measured by ECG
Measured: Day -1-Day 2
Change from baseline in QTcB (QT duration corrected for heart rate by Bazett's formula), QT for GEn (1200 mg and 6000 mg) and moxifloxacin (400 mg) and placebo measured by ECG
Measured: Day -1-Day 2
Change from baseline in PR, QRS intervals, heart rate and ECG waveform morphology for GEn (1200 mg and 6000 mg) and placebo measured by ECG
Measured: Day -1-Day 2
Change from baseline in heart rate and ECG waveform morphology for moxifloxacin (400 mg)
Measured: Day -1-Day 2
Pharmacokinetic parameters for gabapentin and moxifloxacin
Measured: Day -1-Day 2
Safety parameters: AEs, vital signs, ECGs, Columbia Suicide Severity Rating Scale (C-SSRS) and clinical laboratory parameters
Measured: Day -1-Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- XenoPort, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516372
- Sponsor's protocol ID
- 114112
- Status last verified
- Apr 2021
- First submitted
- 19 Jan 2012
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Davy M, Upward J, Arumugham T, Twomey C, Chen C, Stier B. Cardiac repolarization with Gabapentin enacarbil in a randomized, double-blind, placebo- and active-controlled, crossover thorough QT/QTc study in healthy adults. Clin Ther. 2013 Dec;35(12):1964-74. doi: 10.1016/j.clinthera.2013.10.011. Epub 2013 Nov 28.
PubMed 24290737
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single Dose Crossover Study to Assess the Effect of Gabapentin Enacarbil on Cardiac Conduction as Compared With Placebo and Moxifloxacin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01516372
- Acronym / sponsor ID
- 114112
- Conditions
- Restless Legs Syndrome
- Keywords
- GEn, moxifloxacin, cardiac repolarisation, QT/QTc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- XenoPort, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 24 Jan 2012 (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.
This will be a randomized, double-blind, placebo- controlled cross-over study to investigate the effect of GEn on cardiac repolarisation parameters compared with placebo and a positive control, moxifloxacin. Approximately 52 subjects will be recruited to the study and will take part in four dosing sessions. Subjects will receive, in a randomized order, a single dose of 1200 mg GEn, 6000 mg GEn (supratherapeutic dose), 400 mg moxifloxacin (positive control) and placebo. Twelve lead continuous ECG monitoring will be conducted from pre-dose to approximately 24 hours after dosing on Day 1 of each study session. The primary comparison of interest will be the mean change from baseline in the time-matched differences in QTcF between each GEn treatment and placebo.
Detailed description
This is a 4-period, randomized, active-and placebo-controlled, double-dummy, double-blind cross-over study to evaluate the effect of single doses of GEn on cardiac conduction parameters in healthy subjects.
Screening will occur within approximately 28 days of the first scheduled dose of study medication. Each subject will participate in 4 dosing sessions at least one week apart. Prior to dosing in each period, the investigator will review the scheduled assessments to confirm the subject's suitability for the study including review of study entry criteria and lifestyle restrictions.
All subjects will receive single doses of GEn 1200 mg, GEn 6000 mg, moxifloxacin 400 mg and placebo in a randomized sequence.
Dosing with moxifloxacin will be in the fasted state and GEn will be administered following a standard meal. A double dummy approach will be used to maintain blinding. Thus, on each dosing day, moxifloxacin or moxifloxacin placebo will be administered in the fasted state in the morning and GEn or matched placebo will be administered 2 hours later after a standard meal.
During each treatment period, subjects will report to the clinical research unit the day before dosing (Day 1) and will remain until completion of the last assessment on Day 2. Twelve-lead ECGs including continuous Holter monitoring, clinical laboratory safety tests, vital sign measurements, physical examinations, adverse event reports, and pharmacokinetic samples will be collected throughout the study.
In each study period, cardiac conduction will be measured using a 24-hour continuous 12-lead Holter monitor from the morning of Day 1 until the morning of Day 2. Extraction of the Holter monitor data in triplicate for analysis will begin on Day 1 at timepoints indicated in the Time and Events Table (Section 4.7). These timepoints were selected to cover the Cmax of both moxifloxacin and GEn. If no clinically significant abnormalities are noted, subjects will be discharged from the clinical research unit after the completion of all assessments on Day 2 in each period. A minimum 7-day washout period will separate each treatment period. A follow-up visit will be conducted approximately 7 to 14 days after administration of the last dose of study medication in treatment period 4
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: GEn 1200mg, Drug: Moxifloxacin PlaceboHealthy Volunteers will receive Treatments ABDC |
| Treatment 2 | Experimental | Drug: Gen 6000 mg, Drug: Moxifloxacin PlaceboHealthy Volunteers will receive Treatments BCAD |
| Treatment 3 | Experimental | Drug: GEn PlaceboHealthy Volunteers will receive Treatments CDBA |
| Treatment 4 | Experimental | Drug: GEn Placebo, Drug: MoxifloxacinHealthy Volunteers will receive Treatments DACB |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
- Male or female between 18 and 50 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and estradiol less than 40 pg/ml (less than 147 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit is completed.
- Body weight greater than and equal to 50 kg and BMI within the range 19 - 30 kg/m2 (inclusive)
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Key exclusion criteria (19 listed)
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for HIV antibody.
- Has cardiac conduction abnormalities on the screening 12-lead ECG denoted by any of the following: QTcB or QTcF interval greater than 450 msec; PR interval greater than 200 msec or less than and equal to 110 msec; Evidence of second- or third- degree atrioventricular block (AVB); Pathological Q-waves (defined as Q-wave greater than 40 msec or depth greater than 0.4- 0.5mV); Evidence of ventricular pre-excitation; Electrocardiographic evidence of complete left bundle branch block (LBBB), right bundle branch block (RBBB), incomplete LBBB; Intraventricular conduction delay with QRS duration greater than 120 msec
- The subject has a screening heart rate less than 50 or greater than 100 bpm or a systolic blood pressure greater than 140 or less than 100 mmHg or a diastolic blood pressure greater than 90 or ;ess than 60 mmHg in the semisupine position
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 |
|---|---|---|
| GEn 1200mgAlso: gen12001200 mg of Gen administered as a single dose | Drug | Treatment 1 |
| Gen 6000 mgAlso: gen60006000 mg of Gen administered as a single dose | Drug | Treatment 2 |
| GEn PlaceboPlacebo to match GEn Tablets | Drug | Treatment 3, Treatment 4 |
| Moxifloxacin PlaceboPlacebo to match Moxifloxacin | Drug | Treatment 1, Treatment 2 |
| MoxifloxacinAlso: moxifloxacin 400400 mg Moxifloxacin administered as a single dose | Drug | Treatment 4 |
Primary outcome
Change in QTcF (QT duration corrected for heart rate by Fridericia's formula) interval at Each time point for 6000 mg GEn and Placebo measured by ECG
Time frame: Day -1-Day2
7 secondary outcomes
Change in QTcF interval at Each time point for 1200 mg GEn and Placebo measured by ECG
Time frame: Day -1-Day 2
Change from baseline in QTcF interval at each time point for moxifloxacin 400 mg and placebo measured by ECG
Time frame: Day -1-Day 2
Change from baseline in QTcB (QT duration corrected for heart rate by Bazett's formula), QT for GEn (1200 mg and 6000 mg) and moxifloxacin (400 mg) and placebo measured by ECG
Time frame: Day -1-Day 2
Change from baseline in PR, QRS intervals, heart rate and ECG waveform morphology for GEn (1200 mg and 6000 mg) and placebo measured by ECG
Time frame: Day -1-Day 2
Change from baseline in heart rate and ECG waveform morphology for moxifloxacin (400 mg)
Time frame: Day -1-Day 2
Pharmacokinetic parameters for gabapentin and moxifloxacin
Time frame: Day -1-Day 2
Safety parameters: AEs, vital signs, ECGs, Columbia Suicide Severity Rating Scale (C-SSRS) and clinical laboratory parameters
Time frame: Day -1-Day 2
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 12 Apr 2021.
- Derived from this study: PubMed 24290737Davy M, Upward J, Arumugham T, Twomey C, Chen C, Stier B. Cardiac repolarization with Gabapentin enacarbil in a randomized, double-blind, placebo- and active-controlled, crossover thorough QT/QTc study in healthy adults. Clin Ther. 2013 Dec;35(12):1964-74. doi: 10.1016/j.clinthera.2013.10.011. Epub 2013 Nov 28.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 GEn 1200mg, Gen 6000 mg and Moxifloxacin in people with Restless Legs Syndrome, run by XenoPort, Inc. 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 19 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 12 Apr 2021. 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. 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?
Change in QTcF (QT duration corrected for heart rate by Fridericia's formula) interval at Each time point for 6000 mg GEn and Placebo measured by ECG (time frame: Day -1-Day2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01516372, which also lists 1 linked publication.
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 12 Apr 2021.