Tafenoquine/Chloroquine DDI Study

NCT00871156 | Completed Phase 1

• 1 other identifier: 106491
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

DDI study of Tafenoquine and Chloroquine

Conditions

Malaria

Keywords

Drug-Drug Interaction

Outcome Measures

Primary Outcomes (3)

• TQ and Chloroquine (Day 2): AUC(0-tau), Cmax and Tmax

  56 days

• CQ and TQ (Day 3): AUC(0-tau), AUC(0-inf), Cmax, Tmax and t1/2

  56 days

• AEs, vital signs, 12-lead ECGs, telemetry, clinical laboratory and ophthalmic assessments

  56 days

Secondary Outcomes (2)

• QTcF, QT, QRS, RR and HR as assessed by 12-lead ECG

  56 Days

• Changes from baseline in QTcF

  56 days

Study Arms (2)

Part 1

ACTIVE COMPARATOR

Tafenoquine + Chloroquine vs. Chloroquine alone

Drug: Chloroquine, Tafenoquine

Part 2

PLACEBO COMPARATOR

Chloroquine alone, Tafenoquine alone or Chloroquine+Tafenoquine

Drug: Chloroquine, Tafenoquine; Drug: Placebo

Interventions

Chloroquine, Tafenoquine DRUG

Chloroquine and Tafenoquine

Also known as: Tafenoquine, Chloroquine

Part 1; Part 2

Placebo DRUG

Placebo

Also known as: Placeob

Part 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Medicines for Malaria Venture: collaborator

Study Sites (1)

GSK Investigational Site

Buffalo, New York, 14202, United States

Location

Related Publications (1)

• 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.

  PMID: 23701202 BACKGROUND

Related Links

• Results for study 106491 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Malaria

Interventions

Chloroquine; tafenoquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 30, 2009
• Study Start: March 24, 2009
• Primary Completion: August 26, 2009
• Study Completion: August 26, 2009
• Last Updated: June 19, 2017

Record last verified: 2017-06

Locations

US (1)