Malaria, VivaxPhase 1NCT01928914

Tafenoquine Thorough QTc Study in Healthy Subjects

A Phase 1 study testing Tafenoquine 300mg, Tafenoquine 600mg and Tafenoquine 1200mg in people with Malaria, Vivax, run by GlaxoSmithKline at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This will be a randomized, single-blind, placebo controlled, parallel group study. Approximately 260 subjects will be enrolled in five groups. This study is designed to compare the effects of tafenoquine, administered as single dose as well as administered over three consecutive days, on the changes in QT duration to… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Malaria, Vivax
What is being tested?: Tafenoquine 300mg, Tafenoquine 600mg and Tafenoquine 1200mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 260 participants
Where: 2 sitesUnited States
Study dates: 26 Jul 2011to 4 Jun 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

AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and baseline ECG 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.
Male or female between 18 and 65 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) > 40 MlU/ml and estradiol < 40 pg/ml (<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 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 Section 8.1 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 90 days post-last dose.
Body weight ≥50 kg for men and ≥45 kg for women and BMI within the range 18.5 to 31.0 kg/m2 (inclusive).
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Who cannot join

Documented Glucose-6-phosphate dehydrogenase (G6PD) deficiency, determined by a quantitative assay of enzyme activity.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of thalassaemia; or current or past history of methemoglobinemia or methemoglobin percentage above the reference range at screening.
A positive pre-study drug/alcohol screen.
A positive test for HIV antibody.

Show all 33Show fewer

History of 2nd degree or higher AV block.
Donation of blood or blood products in excess of 500 mL within a 56 day period prior to enrolment.
Subjects with a hemoglobin values outside the normal range. A single repeat is allowed for eligibility determination.
The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects or 45-100 bpm for male subjects.
Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination)
PR Interval <120 and >220 msec
QRS Duration <70 and >120 msec
QTc, QTcB or QTcF Interval >450 msec
Heart Rate, for male subjects <45 and >100 bpm, and for female subjects <50 and >100 bpm
Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization).
Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], Wolff Parkinson White [WPW] syndrome).
Sinus Pauses > 3 seconds.
Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject.
Non-sustained or sustained ventricular tachycardia (>3 consecutive ventricular ectopic beats).
History of regular alcohol consumption within 6 months of the study defined as:
An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80o 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.
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.
Pregnant females as determined by positive (serum or urine) hCG test at screening or prior to dosing.
Lactating females.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subject is mentally or legally incapacitated.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

GSK Investigational Site
Baltimore, Maryland, 21225
GSK Investigational Site
Culver City, California, 90232

Other trials in United States

About this study

Official title: A Randomized, Placebo-Controlled Study to Evaluate the Effect of Tafenoquine (SB252263) on the Electrocardiogram (ECG) With Focus on Cardiac Repolarization (QTc Duration) in Healthy Subjects

Read the detailed description

SB-252263 (tafenoquine, TQ) is a new 8-aminoquinoline antimalarial drug being developed by GlaxoSmithKline (GSK) and the Medicines for Malaria Venture with the assistance and historical support of the Walter Reed Army Institute of Research. Tafenoquine has been shown to be effective in the treatment of plasmodial infections in vitro, in pre-clinical models in vivo, and during early phase clinical studies for radical cure and eradication of liver hypnozoites in patients infected with Plasmodium vivax. This study is designed to compare the effects of tafenoquine mono-therapy, administered as a single dose or administered on 3 consecutive days, on the changes in QT duration to those observed in subjects dosed with either Avelox (moxifloxacin hydrochloride) or placebo. This will be a randomized, single-blind, placebo controlled, parallel group study. Parallel group design is chosen because tafenoquine has a long half-life, about 14 to 19 days, and therefore a cross-over design is not a practical alternative. Moxifloxacin will be used as a positive control in order to validate the sensitivity of the study in detecting QTc change. Moxifloxacin has been shown to prolong the QT interval in a dose-dependent manner in patients and healthy volunteers, and the QTc prolongation has been well quantified.

Conditions: Malaria, Vivax
Being tested: Tafenoquine 300mg, Tafenoquine 600mg, Tafenoquine 1200mg, moxifloxacin, Placebo for Tafenoquine
Medical subject headings: Malaria, Vivax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tafenoquine 300mgDrug
Single dose of Tafenoquine give on Day 3 only
Tafenoquine 600mgDrug
Single dose of Tafenoquine given on Day 3 only
Tafenoquine 1200mgDrug
400mg Dose of Tafenoquine given on each of the three consecutive dosing days
moxifloxacinDrug
moxifloxacine given on Day 3 only
Placebo for TafenoquineDrug
Placebo given on all three days to all groups except for group 5 on Day 3
Placebo for moxifloxaxinDrug
Placebo for moxifloxacin, given to all groups on all days except for Group 3 on Day 3

Study groups in NCT01928914
Study group	Role	What they receive
Group 1	Placebo comparator	Subjects in group 1 receive placebo for tafenoquine and placebo for moxifloxacin on three consecutive days of dosing Receives: Drug: Placebo for Tafenoquine; Drug: Placebo for moxifloxaxin
Group 2	Experimental	Subjects in group 2 receive 400mg of tafenoquine and placebo for moxifloxacin on three consecutive days of dosing Receives: Drug: Tafenoquine 1200mg; Drug: Placebo for Tafenoquine
Group 3	Active comparator	Subjects in group 1 receive placebo for tafenoquine and placebo for moxifloxacin on days 1 and 2. On day 3, subjects receive placebo for tafenoquine and 400mg moxifloxacin. Receives: Drug: moxifloxacin; Drug: Placebo for Tafenoquine; Drug: Placebo for moxifloxaxin
Group 4	Experimental	Subjects in group 1 receive placebo for tafenoquine and placebo for moxifloxacin on days 1 and 2. On day 3, subjects receive placebo for moxifloxacin and 300mg of tafenoquine Receives: Drug: Tafenoquine 300mg; Drug: Placebo for Tafenoquine; Drug: Placebo for moxifloxaxin
Group 5	Experimental	Subjects in group 1 receive placebo for tafenoquine and placebo for moxifloxacin on days 1 and 2. On day 3, subjects receive placebo for moxifloxacin and 600mg of tafenoquine Receives: Drug: Tafenoquine 600mg; Drug: Placebo for Tafenoquine; Drug: Placebo for moxifloxaxin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in QTcF for 1200 mg dose of tafenoquine compared to baseline
Contineous QTcF will be electronically recorded using holtor monitors. The primary comparison of interest is the mean time-matched change from baseline in QTcF for the difference tafenoquine-placebo for 1200mg dose of tafenoquine at each timepoint.
Measured: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6

Secondary outcomes (8)

Change from Baseline in QTcB, QTcI, QT, and HR for 1200mg dose of tafenoquine
electronic ECGs collected using holter monitors will be analysed to measure QTcF QTcB, QTcI, QT, and Heart Rate (HR)
Measured: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Change from Baseline in QTcF QTcB, QTcI, QT, and HR for 300 mg single dose of tafenoquine
electronic ECGs collected using holter monitors will be analysed to measure QTcF QTcB, QTcI, QT, and Heart Rate (HR)
Measured: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Change from Baseline in QTcF, QTcB, QTcI, QT, and HR for placebo
electronic ECGs collected using holter monitors will be analysed to measure QTcF QTcB, QTcI, QT, and Heart Rate (HR)
Measured: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Change from Baseline in QTcF, QTcB, QTcI, QT, and HR for moxifloxacin
electronic ECGs collected using holter monitors will be analysed to measure QTcF QTcB, QTcI, QT, and Heart Rate (HR)
Measured: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Plasma concentrations and derived pharmacokinetic parameters AUC(0-t), Cmax, and tmax of tafenoquine
Blood samples will be collected at pre-dose on Days 1 and 2, and Day 3: pre-dose, 1, 2, 3, 4, 5, 6, 9, 12, 15, 20, 24, 36, 48 and 72 hours post Day 3 dose, to measure plasma concentrations and derived pharmacokinetic parameters AUC(0-t), Cmax, and tmax of tafenoquine
Measured: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Safety and tolerability of tafenoquine as assessed by 12-lead ECGs, vital signs, adverse events, and clinical laboratory tests
Safety and tolerability of tafenoquine as assessed by 12-lead ECGs, vital signs, adverse events, and clinical laboratory tests
Measured: Day 1, Day 2 and Day 3
Change from Baseline in QTcF QTcB, QTcI, QT, and HR for 600 mg single dose of tafenoquine
electronic ECGs collected using holter monitors will be analysed to measure QTcF QTcB, QTcI, QT, and Heart Rate (HR)
Measured: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Plasma concentrations and derived pharmacokinetic parameters AUC(0-t), Cmax, and tmax of moxifloxacin
Blood samples will be collected at pre-dose on Days 1 and 2, and Day 3: pre-dose, 1, 2, 3, 4, 5, 6, 9, 12, 15, 20, 24, 36, 48 and 72 hours post Day 3 dose, to measure plasma concentrations and derived pharmacokinetic parameters AUC(0-t), Cmax, and tmax of moxifloxacin
Measured: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 20114 Jun 2012

First posted27 Aug 2013 (estimated)
Study start26 Jul 2011
Primary completion4 Jun 2012
Study completion4 Jun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Malaria, VivaxStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01928914
Sponsor's protocol ID: 114582
Status last verified: Jun 2017
First submitted: 29 Mar 2012
Last updated: 12 Jun 2017
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled Study to Evaluate the Effect of Tafenoquine (SB252263) on the Electrocardiogram (ECG) With Focus on Cardiac Repolarization (QTc Duration) in Healthy Subjects
ClinicalTrials.gov ID: NCT01928914
Acronym / sponsor ID: 114582
Conditions: Malaria, Vivax
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 26 Jul 2011 (actual)
Primary completion: 4 Jun 2012 (actual)
Study completion: 4 Jun 2012 (actual)
First posted: 27 Aug 2013 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
Group 1	Placebo comparator	Drug: Placebo for Tafenoquine, Drug: Placebo for moxifloxaxinSubjects in group 1 receive placebo for tafenoquine and placebo for moxifloxacin on three consecutive days of dosing
Group 2	Experimental	Drug: Tafenoquine 1200mg, Drug: Placebo for TafenoquineSubjects in group 2 receive 400mg of tafenoquine and placebo for moxifloxacin on three consecutive days of dosing
Group 3	Active comparator	Drug: moxifloxacin, Drug: Placebo for Tafenoquine, Drug: Placebo for moxifloxaxinSubjects in group 1 receive placebo for tafenoquine and placebo for moxifloxacin on days 1 and 2. On day 3, subjects receive placebo for tafenoquine and 400mg moxifloxacin.
Group 4	Experimental	Drug: Tafenoquine 300mg, Drug: Placebo for Tafenoquine, Drug: Placebo for moxifloxaxinSubjects in group 1 receive placebo for tafenoquine and placebo for moxifloxacin on days 1 and 2. On day 3, subjects receive placebo for moxifloxacin and 300mg of tafenoquine
Group 5	Experimental	Drug: Tafenoquine 600mg, Drug: Placebo for Tafenoquine, Drug: Placebo for moxifloxaxinSubjects in group 1 receive placebo for tafenoquine and placebo for moxifloxacin on days 1 and 2. On day 3, subjects receive placebo for moxifloxacin and 600mg of tafenoquine

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and baseline ECG 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.
Male or female between 18 and 65 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) > 40 MlU/ml and estradiol < 40 pg/ml (<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 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.

Key exclusion criteria (33 listed)

Documented Glucose-6-phosphate dehydrogenase (G6PD) deficiency, determined by a quantitative assay of enzyme activity.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of thalassaemia; or current or past history of methemoglobinemia or methemoglobin percentage above the reference range at screening.
A positive pre-study drug/alcohol screen.

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
Tafenoquine 300mgSingle dose of Tafenoquine give on Day 3 only	Drug	Group 4
Tafenoquine 600mgSingle dose of Tafenoquine given on Day 3 only	Drug	Group 5
Tafenoquine 1200mg400mg Dose of Tafenoquine given on each of the three consecutive dosing days	Drug	Group 2
moxifloxacinmoxifloxacine given on Day 3 only	Drug	Group 3
Placebo for TafenoquinePlacebo given on all three days to all groups except for group 5 on Day 3	Drug	Group 1, Group 2, Group 3, Group 4, Group 5
Placebo for moxifloxaxinPlacebo for moxifloxacin, given to all groups on all days except for Group 3 on Day 3	Drug	Group 1, Group 3, Group 4, Group 5

Primary outcome

Change from baseline in QTcF for 1200 mg dose of tafenoquine compared to baseline
Time frame: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Contineous QTcF will be electronically recorded using holtor monitors. The primary comparison of interest is the mean time-matched change from baseline in QTcF for the difference tafenoquine-placebo for 1200mg dose of tafenoquine at each timepoint.

8 secondary outcomes

Change from Baseline in QTcB, QTcI, QT, and HR for 1200mg dose of tafenoquine
Time frame: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Change from Baseline in QTcF QTcB, QTcI, QT, and HR for 300 mg single dose of tafenoquine
Time frame: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Change from Baseline in QTcF, QTcB, QTcI, QT, and HR for placebo
Time frame: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Change from Baseline in QTcF, QTcB, QTcI, QT, and HR for moxifloxacin
Time frame: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Plasma concentrations and derived pharmacokinetic parameters AUC(0-t), Cmax, and tmax of tafenoquine
Time frame: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Safety and tolerability of tafenoquine as assessed by 12-lead ECGs, vital signs, adverse events, and clinical laboratory tests
Time frame: Day 1, Day 2 and Day 3
Change from Baseline in QTcF QTcB, QTcI, QT, and HR for 600 mg single dose of tafenoquine
Time frame: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6
Plasma concentrations and derived pharmacokinetic parameters AUC(0-t), Cmax, and tmax of moxifloxacin
Time frame: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6

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 Jun 2017.
Results for study 114582 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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.
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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tafenoquine 300mg, Tafenoquine 600mg and Tafenoquine 1200mg in people with Malaria, Vivax, run by GlaxoSmithKline at 2 sites 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 8 inclusion and 33 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 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Change from baseline in QTcF for 1200 mg dose of tafenoquine compared to baseline (time frame: Day 1, Day 2, day 3, Day 4, Day 5 and Day 6). 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 NCT01928914.

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 Jun 2017.