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Tafenoquine/Chloroquine DDI Study

This study has been completed.
Sponsor:
Collaborator:
Medicines for Malaria Venture
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00871156
First received: March 23, 2009
Last updated: October 15, 2009
Last verified: October 2009
  Purpose

DDI study of Tafenoquine and Chloroquine


Condition Intervention Phase
Healthy Subjects
Healthy Volunteer
Drug: Chloroquine, Tafenoquine
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Safety, Tolerability, and Pharmacokinetic Study of Concomitant Chloroquine and Tafenoquine in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • TQ and Chloroquine (Day 2): AUC(0-tau), Cmax and Tmax [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • CQ and TQ (Day 3): AUC(0-tau), AUC(0-inf), Cmax, Tmax and t1/2 [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • AEs, vital signs, 12-lead ECGs, telemetry, clinical laboratory and ophthalmic assessments [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • QTcF, QT, QRS, RR and HR as assessed by 12-lead ECG [ Time Frame: 56 Days ] [ Designated as safety issue: Yes ]
  • Changes from baseline in QTcF [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: March 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Part 2
Chloroquine alone, Tafenoquine alone or Chloroquine+Tafenoquine
Drug: Chloroquine, Tafenoquine
Chloroquine and Tafenoquine
Other Names:
  • Chloroquine
  • Tafenoquine
Drug: Placebo
Placebo
Other Name: Placeob
Active Comparator: Part 1
Tafenoquine + Chloroquine vs. Chloroquine alone
Drug: Chloroquine, Tafenoquine
Chloroquine and Tafenoquine
Other Names:
  • Chloroquine
  • Tafenoquine

Detailed Description:

Safety, Tolerability, and Pharmacokinetic Study of Concomitant Chloroquine and Tafenoquine in Healthy Volunteers

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871156

Locations
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66219
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202
Sponsors and Collaborators
GlaxoSmithKline
Medicines for Malaria Venture
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00871156     History of Changes
Other Study ID Numbers: 106491
Study First Received: March 23, 2009
Last Updated: October 15, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Drug-Drug Interaction

Additional relevant MeSH terms:
Chloroquine
Chloroquine diphosphate
Tafenoquine
Amebicides
Analgesics
Analgesics, Non-Narcotic
Anthelmintics
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimalarials
Antinematodal Agents
Antiparasitic Agents
Antiprotozoal Agents
Antirheumatic Agents
Central Nervous System Agents
Filaricides
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014