Malaria, VivaxPhase 1NCT02751294

A Study to Assess the Effects of Dissolution Profile on the Pharmacokinetics of Single Oral Doses of Tafenoquine Tablets and Tafenoquine Stable Isotope Labelled Solution

A Phase 1 study testing Tafenoquine dissolution profile X and Tafenoquine SIL in people with Malaria, Vivax, run by GlaxoSmithKline at 1 site 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

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Malaria, Vivax
What is being tested?: Tafenoquine dissolution profile X and Tafenoquine SIL
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: May 2016to Aug 2016
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 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Between 18 and 55 years of age inclusive, at the time of signing the informed consent
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator and the GlaxoSmithKline (GSK) Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Subject values outside the normal range should always be excluded from enrolment.
Body weight between >=35 kilogram (kg) and <=100 kg.
Male subjects only.
Capable of giving signed informed consent as described in study protocol, which includes compliance with the requirements and restrictions listed in the consent form and in the study protocol

Who cannot join

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Alanine Aminotransferase (ALT) and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 450 millisecond (msec) Note: The QTc is the QTcF). Other calculation methods (e.g. QT interval corrected using Bazett's formula [QTcB], QTcF) machine-read or manually over-read are not acceptable.
Use of prescription (except acetaminophen at doses of 2 grams/day) 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 regular alcohol consumption within 30 days of the study defined as: an average weekly intake of >14 drinks for males. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 millilitre [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.

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Positive results for drugs of abuse as mentioned in protocol.
Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 30 days prior to screening.
History of sensitivity to TQ, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
History of thalassaemia; or current or past history of methemoglobinemia or methemoglobin percentage above the reference range at screening.
Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
A positive pre-study drug/alcohol screen.
A positive test for human immunodeficiency virus (HIV) antibody.
The subject has been dosed with TQ within 10 months prior to being dosed in this study.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 15 days of dosing with TQ or matched-placebo.
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.
Subjects with a hemoglobin values outside the lower limit of normal range. A single repeat is allowed for eligibility determination.
Documented phenotypic Glucose-6-phosphate dehydrogenase (G6PD) deficiency, determined by a quantitative assay of enzyme activity. Defined as <70% of locally defined median.

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Randomized, Open-label, Single-period, Parallel-group Study in Healthy Subjects to Determine the Effects of Dissolution Profile on the Pharmacokinetics (Via Both Venous and Peripheral Micro-samples) of Single Oral 300 mg Doses of Tafenoquine (SB-252263) Tablets + 30 mg Tafenoquine Stable Isotope Labelled (SIL) Solution

This study will investigate the effect of Tafenoquine (TQ) 150 mg tablet ageing (dissolution profiles) on human exposure of TQ comparing the relative bioavailability of TQ from tablets exhibiting different dissolution profiles in healthy subjects. This is a single-centre, 2-arm, randomized open-label, parallel-group study in healthy subjects. All subjects will arrive in the unit approximately 24 hours prior to dosing and will be discharged after the 72-hour post-dose assessments are completed. Subjects will return for outpatient visits on Days 7, 14, 21, 28, and 56 after dosing. A total of 14 subjects (n=7 subjects in each arm) are planned to be enrolled. All subjects will receive a single dose of study medication (2x150 mg TQ tablets + 30 mg TQ SIL in solution) and participate through a 56-day post dose follow-up visit. To enable the application of peripheral microsampling in planned paediatric studies, a comparison of the measured pharmacokinetic (PK) exposure via peripheral blood collection (via microsampling) to venous collection will also be performed in this study.

Conditions: Malaria, Vivax
Being tested: Tafenoquine Control, Tafenoquine dissolution profile X, Tafenoquine SIL
Keywords: Healthy Volunteer, Malaria, Pharmacokinetics, Tafenoquine
Medical subject headings: Malaria, Vivax, Malaria

What participants receive

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

Tafenoquine ControlDrug
It will be supplied as a dark pink, capsule-shaped, film-coated tablet plain on both sides containing 150 mg tafenoquine
Tafenoquine dissolution profile XDrug
It will be supplied as a dark pink, capsule-shaped, film-coated tablet plain on both sides containing 150 mg tafenoquine and will be "intermediate aged TQ Product".
Tafenoquine SILDrug
It will be compounded at site and will be administered as 0.3 mg/mL (100mL to be dosed, equivalent to 30 mg) aqueous Solution of SIL Tafenoquine.

Study groups in NCT02751294
Study group	Role	What they receive
TQ Control+ TQ SIL	Experimental	Subjects received TQ Control product (2 tablets) and 30 mg TQ SIL solution orally with water after a meal. Receives: Drug: Tafenoquine Control; Drug: Tafenoquine SIL
TQ X + TQ SIL	Experimental	Subjects received 2 tablets of Tafenoquine dissolution profile X and 30 mg TQ SIL solution orally with water after a meal. Receives: Drug: Tafenoquine dissolution profile X; Drug: Tafenoquine SIL

What is being measured

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

Ratio of the geometric means for the area under plasma concentration-time curve (AUC) for Tafenoquine X
Blood samples for PK analysis of TQ will be collected for evaluation of ratio of the geometric means (90% Confidence Interval [CI]) for the area under plasma concentration-time curve from 0 to time t (AUC [0-t]) and area under the concentration-time curve from 0 to infinity (AUC[0-inf]) for the treatment group dissolution profile X compared to Control.
Measured: Samples will be collected at Pre-dose and 1, 2, 6, 9, 12, 15, 20, 24, 36, 48, 60, and 72 hours post dose on Day 1 and single sample on Day 7, 14, 21, 28, and 56

Secondary outcomes (11)

Safety as assessed by clinical monitoring of blood pressure
Systolic and diastolic blood pressure will be measured in semi-supine position after approximately 5 minutes rest. Blood pressure will be measured at pre-dose (at least 30 min. prior to dosing and at least 15 min. after waking) and at 12 hours post dose.
Measured: Up to 12 hours
Safety as assessed by clinical monitoring of pulse rate
Pulse rate will be measured in semi-supine position after approximately 5 minutes rest. Pulse rate will be measured at pre-dose (at least 30 min. prior to dosing and at least 15 min. after waking) and at 12 hours post dose.
Measured: Up to 12 hours
Safety as assessed by clinical monitoring of electrocardiogram (ECGs)
Single 12-lead ECGs will be obtained in the semi-supine position at screening using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate according to Fridericia's formula (QTcF) intervals
Measured: Day -1
Safety as assessed by clinical monitoring of Haematology parameters
Haematology parameters include Platelet Count, red blood cell (RBC) Indices, white blood cell (WBC) count with differential, RBC Count, mean cell volume (MCV), neutrophils, hemoglobin, mean corpuscular hemoglobin (MCH), lymphocytes, hematocrit, monocytes, methemoglobin %, eosinophils and basophils. It will be assessed on Day -1, Pre-dose and post-dose at Day 7 and Day 14.
Measured: Up to Day 14
Safety as assessed by clinical monitoring of Clinical Chemistry parameters
Clinical chemistry parameters includes blood urea nitrogen, potassium, aspartate aminotransferase (SGOT), total and direct bilirubin, creatinine, sodium, alanine aminotransferase (SGPT), total protein, glucose, calcium, alkaline phosphatase and albumin. It will be assessed on Day -1, Pre-dose and post-dose at Day 7 and Day 14.
Measured: Up to Day 14
Safety as assessed by clinical monitoring of Urinalysis parameters
Urinalysis parameters include specific gravity, pH, glucose, protein, blood and ketones. It will be assessed on Day -1, Pre-dose and post-dose at Day 7 and Day 14
Measured: Up to Day 14
Number of participants with adverse events (AE)
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal.
Measured: Up to Day 63
Area under the plasma concentration-time curve from time 0 to last measurable concentration (AUC0-t) for Tafenoquine
PK samples will be obtained from venous blood and peripheral blood collection (via microsampling)
Measured: Samples will be collected at Pre-dose and 1, 2, 6, 9, 12, 15, 20, 24, 36, 48, 60, and 72 hours post dose on Day 1 and single sample on Day 7, 14, 21, 28, and 56
Maximum plasma concentration (Cmax) for Tafenoquine
PK samples will be obtained from venous blood and peripheral blood collection (via microsampling)
Measured: Samples will be collected at Pre-dose and 1, 2, 6, 9, 12, 15, 20, 24, 36, 48, 60, and 72 hours post dose on Day 1 and single sample on Day 7, 14, 21, 28, and 56
Time to Cmax (tmax) for Tafenoquine
PK samples will be obtained from venous blood and peripheral blood collection (via microsampling)
Measured: Samples will be collected at Pre-dose and 1, 2, 6, 9, 12, 15, 20, 24, 36, 48, 60, and 72 hours post dose on Day 1 and single sample on Day 7, 14, 21, 28, and 56
Terminal half-life (t1/2) for Tafenoquine
PK samples will be obtained from venous blood and peripheral blood collection (via microsampling)
Measured: Samples will be collected at Pre-dose and 1, 2, 6, 9, 12, 15, 20, 24, 36, 48, 60, and 72 hours post dose on Day 1 and single sample on Day 7, 14, 21, 28, and 56

Timeline

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

May 2016Aug 2016

First posted26 Apr 2016 (estimated)
Study startMay 2016
Primary completionAug 2016
Study completionAug 2016

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 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02751294
Sponsor's protocol ID: 201780
Status last verified: Jan 2017
First submitted: 21 Apr 2016
Last updated: 20 Jan 2017
Results posted: No
Data monitoring committee: No

Publications

Goyal N, Mohamed K, Rolfe K, Sahota S, Ernest T, Duparc S, Taylor M, Casillas L, Koh GCKW. Application of the Stable Isotope Label Approach in Clinical Development-Supporting Dissolution Specifications for a Commercial Tablet Product with Tafenoquine, a Long Half-life Compound. AAPS J. 2018 Jun 4;20(4):74. doi: 10.1208/s12248-018-0234-5.
PubMed 29869298

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?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Single-period, Parallel-group Study in Healthy Subjects to Determine the Effects of Dissolution Profile on the Pharmacokinetics (Via Both Venous and Peripheral Micro-samples) of Single Oral 300 mg Doses of Tafenoquine (SB-252263) Tablets + 30 mg Tafenoquine Stable Isotope Labelled (SIL) Solution
ClinicalTrials.gov ID: NCT02751294
Acronym / sponsor ID: 201780
Conditions: Malaria, Vivax
Keywords: Healthy Volunteer, Malaria, Pharmacokinetics, Tafenoquine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Medicines for Malaria Venture, Parexel
Study start: May 2016
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 26 Apr 2016 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TQ Control+ TQ SIL	Experimental	Drug: Tafenoquine Control, Drug: Tafenoquine SILSubjects received TQ Control product (2 tablets) and 30 mg TQ SIL solution orally with water after a meal.
TQ X + TQ SIL	Experimental	Drug: Tafenoquine dissolution profile X, Drug: Tafenoquine SILSubjects received 2 tablets of Tafenoquine dissolution profile X and 30 mg TQ SIL solution orally with water after a meal.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Between 18 and 55 years of age inclusive, at the time of signing the informed consent
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator and the GlaxoSmithKline (GSK) Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Subject values outside the normal range should always be excluded from enrolment.

Key exclusion criteria (19 listed)

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Alanine Aminotransferase (ALT) and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 450 millisecond (msec) Note: The QTc is the QTcF). Other calculation methods (e.g. QT interval corrected using Bazett's formula [QTcB], QTcF) machine-read or manually over-read are not acceptable.
Use of prescription (except acetaminophen at doses of 2 grams/day) 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.

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 ControlIt will be supplied as a dark pink, capsule-shaped, film-coated tablet plain on both sides containing 150 mg tafenoquine	Drug	TQ Control+ TQ SIL
Tafenoquine dissolution profile XIt will be supplied as a dark pink, capsule-shaped, film-coated tablet plain on both sides containing 150 mg tafenoquine and will be "intermediate aged TQ Product".	Drug	TQ X + TQ SIL
Tafenoquine SILIt will be compounded at site and will be administered as 0.3 mg/mL (100mL to be dosed, equivalent to 30 mg) aqueous Solution of SIL Tafenoquine.	Drug	TQ Control+ TQ SIL, TQ X + TQ SIL

Primary outcome

Ratio of the geometric means for the area under plasma concentration-time curve (AUC) for Tafenoquine X
Time frame: Samples will be collected at Pre-dose and 1, 2, 6, 9, 12, 15, 20, 24, 36, 48, 60, and 72 hours post dose on Day 1 and single sample on Day 7, 14, 21, 28, and 56
Blood samples for PK analysis of TQ will be collected for evaluation of ratio of the geometric means (90% Confidence Interval [CI]) for the area under plasma concentration-time curve from 0 to time t (AUC [0-t]) and area under the concentration-time curve from 0 to infinity (AUC[0-inf]) for the treatment group dissolution profile X compared to Control.

11 secondary outcomes

Safety as assessed by clinical monitoring of blood pressure
Time frame: Up to 12 hours
Safety as assessed by clinical monitoring of pulse rate
Time frame: Up to 12 hours
Safety as assessed by clinical monitoring of electrocardiogram (ECGs)
Time frame: Day -1
Safety as assessed by clinical monitoring of Haematology parameters
Time frame: Up to Day 14
Safety as assessed by clinical monitoring of Clinical Chemistry parameters
Time frame: Up to Day 14
Safety as assessed by clinical monitoring of Urinalysis parameters
Time frame: Up to Day 14
Number of participants with adverse events (AE)
Time frame: Up to Day 63
Area under the plasma concentration-time curve from time 0 to last measurable concentration (AUC0-t) for Tafenoquine
Time frame: Samples will be collected at Pre-dose and 1, 2, 6, 9, 12, 15, 20, 24, 36, 48, 60, and 72 hours post dose on Day 1 and single sample on Day 7, 14, 21, 28, and 56
Maximum plasma concentration (Cmax) for Tafenoquine
Time frame: Samples will be collected at Pre-dose and 1, 2, 6, 9, 12, 15, 20, 24, 36, 48, 60, and 72 hours post dose on Day 1 and single sample on Day 7, 14, 21, 28, and 56
Time to Cmax (tmax) for Tafenoquine
Time frame: Samples will be collected at Pre-dose and 1, 2, 6, 9, 12, 15, 20, 24, 36, 48, 60, and 72 hours post dose on Day 1 and single sample on Day 7, 14, 21, 28, and 56
Terminal half-life (t1/2) for Tafenoquine
Time frame: Samples will be collected at Pre-dose and 1, 2, 6, 9, 12, 15, 20, 24, 36, 48, 60, and 72 hours post dose on Day 1 and single sample on Day 7, 14, 21, 28, and 56

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 20 Jan 2017.
Derived from this study: PubMed 29869298Goyal N, Mohamed K, Rolfe K, Sahota S, Ernest T, Duparc S, Taylor M, Casillas L, Koh GCKW. Application of the Stable Isotope Label Approach in Clinical Development-Supporting Dissolution Specifications for a Commercial Tablet Product with Tafenoquine, a Long Half-life Compound. AAPS J. 2018 Jun 4;20(4):74. doi: 10.1208/s12248-018-0234-5.

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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 Tafenoquine dissolution profile X and Tafenoquine SIL in people with Malaria, Vivax, 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 8 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 20 Jan 2017. 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?

Ratio of the geometric means for the area under plasma concentration-time curve (AUC) for Tafenoquine X (time frame: Samples will be collected at Pre-dose and 1, 2, 6, 9, 12, 15, 20, 24, 36, 48, 60, and 72 hours post dose on Day 1 and single sample on Day 7, 14, 21, 28, and 56). 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 NCT02751294, 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 20 Jan 2017.