MalariaPhase 1NCT00871156
Tafenoquine/Chloroquine DDI Study
A Phase 1 study testing Chloroquine, Tafenoquine in people with Malaria, run by GlaxoSmithKline at 1 site in United States.
Trial summary
DDI study of Tafenoquine and Chloroquine Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Chloroquine, Tafenoquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2009to 26 Aug 2009
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECGs. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the Investigator and GSK medical monitor agree that the abnormality will not introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 55 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 or of child-bearing potential if has a negative urine pregnancy test at screening and Day -1, and agrees to use agreed upon contraception methods until 56 days after stopping study drug.
- Body weight >=60 kg (132 pounds) and BMI within the range 19-32 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
- A positive urine drug/alcohol screen at screening or Day -1.
- History or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
- History of illicit drug abuse within 6 months prior to screening.
- History of regular alcohol consumption within 6 months of the study
- Subjects who are unwilling to comply with the lifestyle guidelines required.
- 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).
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- 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.
- History of sensitivity to any of the study medications or their components.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive urine hCG test at screening or prior to dosing.
- Lactating females.
- Subject is mentally or legally incapacitated.
- A positive HIV antibody, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- The subject's systolic blood pressure is outside the range of 90-150mmHg or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects and 45-100bpm for male subjects at screening and Day -1.
- Cardiac conduction abnormalities as specified inprotocol
- Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject.
- History of angina, ischemic heart disease, myocardial infarction, or clinically significant arrhythmia.
- History of epilepsy, convulsions or psychological disorders.
- History of porphyria.
- AST, ALT or alkaline phosphatase >1.5 times the upper limit of normal and/or total bilirubin level outside the normal range at screening. A single repeat is allowed for eligibility determination.
- Documented Glucose-6-phosphate dehydrogenase (G6PD) deficiency, determined by a quantitative assay of enzyme activity.
- History of hemoglobinopathy; or current or past history of methemoglobinemia or methemoglobin percentage above the reference range at screening.
- History of previous eye surgery involving the retina, Lasik surgery within 90 days, or retinal/corneal abnormalities.
- Any clinically significant abnormalities on the screening Humphrey 10-2 visual field test.
- Best corrected visual acuity worse than 0.3 logMAR (20/40 Snellen equivalent) (i.e., 20/40 or better vision will be allowed on study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, and Pharmacokinetic Study of Concomitant Chloroquine and Tafenoquine in Healthy Volunteers
DDI study of Tafenoquine and Chloroquine
Read the detailed description
Safety, Tolerability, and Pharmacokinetic Study of Concomitant Chloroquine and Tafenoquine in Healthy Volunteers
- Conditions
- Malaria
- Being tested
- Chloroquine, Tafenoquine, Placebo
- Keywords
- Drug-Drug Interaction
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroquine, TafenoquineDrug
Also called Tafenoquine, Chloroquine
Chloroquine and Tafenoquine
PlaceboDrug
Also called Placeob
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Active comparator | Tafenoquine + Chloroquine vs. Chloroquine alone Receives: Drug: Chloroquine, Tafenoquine |
| Part 2 | Placebo comparator | Chloroquine alone, Tafenoquine alone or Chloroquine+Tafenoquine Receives: Drug: Chloroquine, Tafenoquine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TQ and Chloroquine (Day 2): AUC(0-tau), Cmax and Tmax
Measured: 56 days
CQ and TQ (Day 3): AUC(0-tau), AUC(0-inf), Cmax, Tmax and t1/2
Measured: 56 days
AEs, vital signs, 12-lead ECGs, telemetry, clinical laboratory and ophthalmic assessments
Measured: 56 days
Secondary outcomes (2)
QTcF, QT, QRS, RR and HR as assessed by 12-lead ECG
Measured: 56 Days
Changes from baseline in QTcF
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study start24 Mar 2009
- Primary completion26 Aug 2009
- Study completion26 Aug 2009
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 MalariaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicines for Malaria Venture
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871156
- Sponsor's protocol ID
- 106491
- Status last verified
- Jun 2017
- First submitted
- 23 Mar 2009
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller AK, Harrell E, Ye L, Baptiste-Brown S, Kleim JP, Ohrt C, Duparc S, Mohrle JJ, Webster A, Stinnett S, Hughes A, Griffith S, Beelen AP. Pharmacokinetic interactions and safety evaluations of coadministered tafenoquine and chloroquine in healthy subjects. Br J Clin Pharmacol. 2013 Dec;76(6):858-67. doi: 10.1111/bcp.12160.
PubMed 23701202
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetic Study of Concomitant Chloroquine and Tafenoquine in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00871156
- Acronym / sponsor ID
- 106491
- Conditions
- Malaria
- Keywords
- Drug-Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Medicines for Malaria Venture
- Study start
- 24 Mar 2009 (actual)
- Primary completion
- 26 Aug 2009 (actual)
- Study completion
- 26 Aug 2009 (actual)
- First posted
- 30 Mar 2009 (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.
DDI study of Tafenoquine and Chloroquine
Detailed description
Safety, Tolerability, and Pharmacokinetic Study of Concomitant Chloroquine and Tafenoquine in Healthy Volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Active comparator | Drug: Chloroquine, TafenoquineTafenoquine + Chloroquine vs. Chloroquine alone |
| Part 2 | Placebo comparator | Drug: Chloroquine, Tafenoquine, Drug: PlaceboChloroquine alone, Tafenoquine alone or Chloroquine+Tafenoquine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECGs. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the Investigator and GSK medical monitor agree that the abnormality will not introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 55 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 or of child-bearing potential if has a negative urine pregnancy test at screening and Day -1, and agrees to use agreed upon contraception methods until 56 days after stopping study drug.
- Body weight >=60 kg (132 pounds) and BMI within the range 19-32 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 (25 listed)
- A positive urine drug/alcohol screen at screening or Day -1.
- History or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
- History of illicit drug abuse within 6 months prior to screening.
- History of regular alcohol consumption within 6 months of the study
- Subjects who are unwilling to comply with the lifestyle guidelines required.
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 |
|---|---|---|
| Chloroquine, TafenoquineAlso: Tafenoquine, ChloroquineChloroquine and Tafenoquine | Drug | Part 1, Part 2 |
| PlaceboAlso: PlaceobPlacebo | Drug | Part 2 |
Primary outcome
TQ and Chloroquine (Day 2): AUC(0-tau), Cmax and Tmax
Time frame: 56 days
CQ and TQ (Day 3): AUC(0-tau), AUC(0-inf), Cmax, Tmax and t1/2
Time frame: 56 days
AEs, vital signs, 12-lead ECGs, telemetry, clinical laboratory and ophthalmic assessments
Time frame: 56 days
2 secondary outcomes
QTcF, QT, QRS, RR and HR as assessed by 12-lead ECG
Time frame: 56 Days
Changes from baseline in QTcF
Time frame: 56 days
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 2017.
- Background: PubMed 23701202Miller AK, Harrell E, Ye L, Baptiste-Brown S, Kleim JP, Ohrt C, Duparc S, Mohrle JJ, Webster A, Stinnett S, Hughes A, Griffith S, Beelen AP. Pharmacokinetic interactions and safety evaluations of coadministered tafenoquine and chloroquine in healthy subjects. Br J Clin Pharmacol. 2013 Dec;76(6):858-67. doi: 10.1111/bcp.12160.
- Results for study 106491 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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 Chloroquine, Tafenoquine in people with Malaria, 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 5 inclusion and 25 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 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. 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?
TQ and Chloroquine (Day 2): AUC(0-tau), Cmax and Tmax (time frame: 56 days). 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 NCT00871156, 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 2017.