EpilepsyPhase 1NCT01583036
An Open-label, Single-centre Study Evaluating the Pharmacokinetics of Digoxin Alone and When Administered at Various Doses of Ezogabine/Retigabine in Healthy Adults. The Pharmacokinetics of Ezogabine/Retigabine and the N-acetyl Metabolite of Ezogabine/Retigabine (NAMR) Will Also be Assessed
A Phase 1 study testing Digoxin Alone and Digoxin + Retigabine in people with Epilepsy, run by GlaxoSmithKline at 1 site in United States.
Trial summary
An interaction study to assess the effect of the ezogabine/retigabine and the main metabolite NAMR on the pharmacokinetics of digoxin in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Digoxin Alone and Digoxin + Retigabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2012to 17 Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. 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.
- 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 the protocol 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 should 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 1 week post-last dose of ezogabine/retigabine.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until at least 1 week post-last dose.
- BMI of 18 to 30 kg/m2 and total body weight greater than 50 kg (110 lbs).
- Normal creatinine clearance assessed by the Cockcroft-Gault Method.
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- Subject's aspartate aminotransferase, ALT, alkaline phosphatase, and bilirubin are greater than and equal to 1.5 × ULN (isolated bilirubin greater than 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).
- Subject is a nonsmoker (defined as a nonsmoker during the last 3 months prior to Screening and have a negative cotinine test at screening).
- Subject has a negative drug screen (amphetamines, barbiturates, cocaine metabolites, opiates, benzodiazepines, and cannabinoids) at Screening and at check-in at Day -1.
- Subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Subject has positive test results for hepatitis B surface antigen, positive hepatitis C virus, or human immunodeficiency virus (HIV)-1 or -2 at Screening
- 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.
- Presence of proteinuria (at least ++) or hematuria or other clinically significant findings in urinalysis at screening.
- Has a history of urinary retention or risk factors for urinary retention that in the Investigator's judgment could potentially affect subject safety.
- Subject has a history of syncope, clinically significant palpitations, bradyarrhythmia or tachyarrhythmia conduction abnormality (e.g., atrioventricular block of any degree, e.g., left bundle-branch block, right bundle-branch block), or Wolf-ParkinsonWhite syndrome, or any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, ECG, or immunogenicity test
- Subject's blood pressure is greater than and equal to 140/90 mm Hg or heart rate is greater than 100 beats/min at Screening; repeat blood pressures should be taken if the subject's blood pressure is greater than and equal to 140/90 mm Hg and if the results are consistently greater than and equal to 140/90 mm Hg, then the subject should be excluded and advised to consult a physician.
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- Subject's QTc interval is greater than 450 ms (per ECG machine interpretation) at screening; repeat measurement should be taken if the QTc greater than 450 ms and if the results are consistently greater than 450 ms, then the subject should be excluded
- Female subject is pregnant or breast-feeding
- Subject has a history of any anaphylactic reaction to any drug or a known hypersensitivity to: LANOXIN/digoxin and/or its excipients, or other digoxin-like medications; or Ezogabine/retigabine; History of sensitivity to any of the study medications, 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.
- Subject has a history of significant cardiovascular or pulmonary dysfunction prior to Screening
- Subject has a fasting triglyceride level greater than 300 mg/dL at Screening
- Subject has a current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert syndrome or asymptomatic gallstones)
- Subject has a history of alcohol or substance abuse within the last 2 years
- Subject has donated blood in the excess of 500 mL within 56 days prior to dosing or intention of donating in the month after completing the study
- Subject has a history of gastrointestinal surgery which could influence gastric emptying (e.g., gastrectomy, gastric bypass)
- Subject has a history of inflammatory bowel disease or irritable bowel syndrome
- Subject has received an investigational drug within 30 days prior to dosing with study medication or 5 half-lives, whichever is longer
- Subject is unlikely to comply with the study protocol and/or to complete the study or required study procedures or is unlikely or unable to return for follow-up visits
- Subject has used prescription medications or over-the-counter medications, herbal supplements, or multivitamins within 14 days prior to dosing with any study medication (beginning with the first dose of digoxin) (see Section 9.2 for additional details)
- Subject has consumed grapefruit juice, cranberry products (such as juice, fruit, or nutritional supplements), or alcohol, caffeine , or xanthine-containing products within 7 days (or 5 elimination half lives whichever is shorter) prior to start the dosing with study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interaction Study to Assess the Effect of the Ezogabine/Retigabine and the Main Metabolite NAMR on the Pharmacokinetics of Digoxin in Healthy Volunteers
An interaction study to assess the effect of the ezogabine/retigabine and the main metabolite NAMR on the pharmacokinetics of digoxin in healthy volunteers
Read the detailed description
This is an open-label, single-centre study to evaluate the pharmacokinetics of single-dose digoxin alone and when administered at various up titration doses of ezogabine/retigabine in healthy adult subjects. The pharmacokinetics of ezogabine/retigabine and the n-acetyl metabolite of ezogabine/retigabine (NAMR) will also be assessed.
- Conditions
- Epilepsy
- Being tested
- Digoxin Alone, Digoxin + Retigabine
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digoxin AloneDrug
Single administration of digoxin 0.25mg
Digoxin + RetigabineDrug
Increasing doses of retigabine (300mg, 450mg, 600mg, 750mg, 900mg, 1050mg and 1200mg) administered as TID doses over 44 days. Co-administration with digoxin (0.25mg) on days 10, 24 and 38.
| Study group | Role | What they receive |
|---|---|---|
| Session 1 digoxin alone, Session 2 retigabine plus digoxin | Experimental | Session 1: Single administration of digoxin (0.25mg) and PK assessments up to 144hrs post-dose. Session 2: Retigabine up-titration to 1200mg (TDD) with co-administration of digoxin (0.25mg) at 3 doses or retigabine during the up-titration (600mg, 900mg and 1200mg) and PK assessments up to 144hrs post-dose following wach co-administration. Receives: Drug: Digoxin Alone; Drug: Digoxin + Retigabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of digoxin from zero hours to infinity (Session 1 day 1 & Session 2 days 10, 24 and 38)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose
CLr (Renal clearance) of digoxin. Session 1 day 1 & Session 2 days 10, 24 and 38
Measured: 0 to 12 hours, 12 to 24 hours, and 24 to 48 hours post dose
CL/F (Apparent clearance following oral dosing) of digoxin/ Session 1 day 1 & Session 2 days 10, 24 and 38
Measured: 0 to 12 hours, 12 to 24 hours, and 24 to 48 hours post dose
Secondary outcomes (10)
Cmax (Maximum observed concentration) of digoxin. Session 1 day 1 & Session 2 days 10, 24 and 38
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose
Tmax (Time of occurrence of Cmax) of digoxin. Session 1 day 1 & Session 2 days 10, 24 and 38
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose
T 1/2 (Terminal phase half-life) of digoxin. Session 1 day 1 & Session 2 days 10, 24 and 38
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose
Area under the curve of digoxin from zero to 48 hours. Session 1 day 1 & Session 2 days 10, 24 and 38
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose
Area under the curve of digoxin from zero to 144 hours. Session 1 day 1 & Session 2 days 10, 24 and 38
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose
Ae (Urinary recovery of unchanged drug) of digoxin from zero to 48 hours. Session 1 day 1 & Session 2 days 10, 24 and 38
Measured: 0 to 12 hours, 12 to 24 hours, and 24 to 48 hours post dose
Cmax of NAMR and ezogabine / retigabine. Days 10, 24 and 38
Measured: pre dose, 0.25, 0.5 1, 1.5, 2, 3, 4, 6, and 8, hours post dose.
Tmax of NAMR and ezogabine / retigabine. Days 10, 24 and 38
Measured: pre dose, 0.25, 0.5 1, 1.5, 2, 3, 4, 6, and 8, hours post dose.
Area under the curve of NAMR and ezogabine / retigabine from zero hours to τ (Time of last observed quantifiable concentration). Days 10, 24 and 38
Measured: pre dose, 0.25, 0.5 1, 1.5, 2, 3, 4, 6, and 8, hours post dose.
Safety and Tolerability (AE's, clinical laboratory, vital signs assessments, ECG's and C-SSRs)
Measured: Session 1 day 1 to Session 2 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study start16 Jan 2012
- Primary completion17 Apr 2012
- Study completion17 Apr 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 EpilepsyStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583036
- Sponsor's protocol ID
- 116216
- Status last verified
- Jun 2018
- First submitted
- 15 Mar 2012
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Tompson DJ, Crean CS, Buraglio M, Arumugham T. Lack of effect of ezogabine/retigabine on the pharmacokinetics of digoxin in healthy individuals: results from a drug-drug interaction study. Clin Pharmacol. 2014 Oct 13;6:149-59. doi: 10.2147/CPAA.S64131. eCollection 2014.
PubMed 25342921
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interaction Study to Assess the Effect of the Ezogabine/Retigabine and the Main Metabolite NAMR on the Pharmacokinetics of Digoxin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01583036
- Acronym / sponsor ID
- 116216
- Conditions
- Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2012 (actual)
- Primary completion
- 17 Apr 2012 (actual)
- Study completion
- 17 Apr 2012 (actual)
- First posted
- 23 Apr 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.
An interaction study to assess the effect of the ezogabine/retigabine and the main metabolite NAMR on the pharmacokinetics of digoxin in healthy volunteers
Detailed description
This is an open-label, single-centre study to evaluate the pharmacokinetics of single-dose digoxin alone and when administered at various up titration doses of ezogabine/retigabine in healthy adult subjects. The pharmacokinetics of ezogabine/retigabine and the n-acetyl metabolite of ezogabine/retigabine (NAMR) will also be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Session 1 digoxin alone, Session 2 retigabine plus digoxin | Experimental | Drug: Digoxin Alone, Drug: Digoxin + RetigabineSession 1: Single administration of digoxin (0.25mg) and PK assessments up to 144hrs post-dose. Session 2: Retigabine up-titration to 1200mg (TDD) with co-administration of digoxin (0.25mg) at 3 doses or retigabine during the up-titration (600mg, 900mg and 1200mg) and PK assessments up to 144hrs post-dose following wach co-administration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. 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.
- 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 the protocol 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 should 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 1 week post-last dose of ezogabine/retigabine.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until at least 1 week post-last dose.
- BMI of 18 to 30 kg/m2 and total body weight greater than 50 kg (110 lbs).
Key exclusion criteria (20 listed)
- Subject has positive test results for hepatitis B surface antigen, positive hepatitis C virus, or human immunodeficiency virus (HIV)-1 or -2 at Screening
- 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.
- Presence of proteinuria (at least ++) or hematuria or other clinically significant findings in urinalysis at screening.
- Has a history of urinary retention or risk factors for urinary retention that in the Investigator's judgment could potentially affect subject safety.
- Subject has a history of syncope, clinically significant palpitations, bradyarrhythmia or tachyarrhythmia conduction abnormality (e.g., atrioventricular block of any degree, e.g., left bundle-branch block, right bundle-branch block), or Wolf-ParkinsonWhite syndrome, or any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, ECG, or immunogenicity test
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 |
|---|---|---|
| Digoxin AloneSingle administration of digoxin 0.25mg | Drug | Session 1 digoxin alone, Session 2 retigabine plus digoxin |
| Digoxin + RetigabineIncreasing doses of retigabine (300mg, 450mg, 600mg, 750mg, 900mg, 1050mg and 1200mg) administered as TID doses over 44 days. Co-administration with digoxin (0.25mg) on days 10, 24 and 38. | Drug | Session 1 digoxin alone, Session 2 retigabine plus digoxin |
Primary outcome
Area under the curve of digoxin from zero hours to infinity (Session 1 day 1 & Session 2 days 10, 24 and 38)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose
CLr (Renal clearance) of digoxin. Session 1 day 1 & Session 2 days 10, 24 and 38
Time frame: 0 to 12 hours, 12 to 24 hours, and 24 to 48 hours post dose
CL/F (Apparent clearance following oral dosing) of digoxin/ Session 1 day 1 & Session 2 days 10, 24 and 38
Time frame: 0 to 12 hours, 12 to 24 hours, and 24 to 48 hours post dose
10 secondary outcomes
Cmax (Maximum observed concentration) of digoxin. Session 1 day 1 & Session 2 days 10, 24 and 38
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose
Tmax (Time of occurrence of Cmax) of digoxin. Session 1 day 1 & Session 2 days 10, 24 and 38
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose
T 1/2 (Terminal phase half-life) of digoxin. Session 1 day 1 & Session 2 days 10, 24 and 38
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose
Area under the curve of digoxin from zero to 48 hours. Session 1 day 1 & Session 2 days 10, 24 and 38
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose
Area under the curve of digoxin from zero to 144 hours. Session 1 day 1 & Session 2 days 10, 24 and 38
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose
Ae (Urinary recovery of unchanged drug) of digoxin from zero to 48 hours. Session 1 day 1 & Session 2 days 10, 24 and 38
Time frame: 0 to 12 hours, 12 to 24 hours, and 24 to 48 hours post dose
Cmax of NAMR and ezogabine / retigabine. Days 10, 24 and 38
Time frame: pre dose, 0.25, 0.5 1, 1.5, 2, 3, 4, 6, and 8, hours post dose.
Tmax of NAMR and ezogabine / retigabine. Days 10, 24 and 38
Time frame: pre dose, 0.25, 0.5 1, 1.5, 2, 3, 4, 6, and 8, hours post dose.
Area under the curve of NAMR and ezogabine / retigabine from zero hours to τ (Time of last observed quantifiable concentration). Days 10, 24 and 38
Time frame: pre dose, 0.25, 0.5 1, 1.5, 2, 3, 4, 6, and 8, hours post dose.
Safety and Tolerability (AE's, clinical laboratory, vital signs assessments, ECG's and C-SSRs)
Time frame: Session 1 day 1 to Session 2 follow-up
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 19 Jun 2018.
- Background: PubMed 25342921Tompson DJ, Crean CS, Buraglio M, Arumugham T. Lack of effect of ezogabine/retigabine on the pharmacokinetics of digoxin in healthy individuals: results from a drug-drug interaction study. Clin Pharmacol. 2014 Oct 13;6:149-59. doi: 10.2147/CPAA.S64131. eCollection 2014.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 116216 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 Digoxin Alone and Digoxin + Retigabine in people with Epilepsy, run by GlaxoSmithKline 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 10 inclusion and 20 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 19 Jun 2018. 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?
Area under the curve of digoxin from zero hours to infinity (Session 1 day 1 & Session 2 days 10, 24 and 38) (time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120 and 144 hours post dose). 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?
On the ClinicalTrials.gov record for NCT01583036, 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 19 Jun 2018.