Last updated on January 2019

Long-Term Safety Study of Tafenoquine

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 - 55 Years
  • Gender: Male or Female

Main Inclusion Criteria:

  1. Completion of the written informed consent process (signed).
  2. Male or female age 18 to 55 years inclusive, in good health as assessed by the Investigator.
  3. Normal G6PD enzyme activity levels as defined by the parameters of the specific G6PD test employed at the local laboratory.
  4. Negative HBsAg and HCV, HIV-1, HIV-2 antibody screen at the screening visit.
  5. Negative serum pregnancy test.
  6. Use acceptable method of birth control.
  7. Hematology, biochemistry and urinalysis results at screening that are within the local laboratory reference range or, if outside the range, not clinically significant as judged by the Investigator in accordance with approved clinically acceptable laboratory ranges, documented prior to study start.
  8. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Main Exclusion Criteria:

  1. History of allergy or intolerance to tafenoquine, primaquine or any excipients.
  2. History of thalassemia or current or past history of methemoglobinemia or methemoglobin >2% at screening.
  3. History of eye disease or surgery
  4. Having previously received hydroxychloroquine for skin conditions or rheumatological diseases, chloroquine for malaria, tamoxifen, amiodarone or other drugs that may affect the optic nerve/retina/cornea within 30 days or 5 half-lives (whichever is longer) of study start. There are no travel restrictions, but the choice of concurrent anti-malarial must be atovaquone-proguanil if the participant chooses to take a registered antimalarial drug while travelling.
  5. Any current diagnosis of Axis I psychiatric disorders

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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