Status:
COMPLETED
Long-Term Safety Study of Tafenoquine
Lead Sponsor:
60 Degrees Pharmaceuticals LLC
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This randomized, double-blind, placebo controlled study will involve 600 healthy (Glucose-6-Phosphate Dehydrogenase \[G6PD\] normal) volunteers. Participants who meet the eligibility criteria will be ...
Eligibility Criteria
Inclusion
- Main
- Completion of the written informed consent process (signed).
- Male or female age 18 to 55 years inclusive, in good health as assessed by the Investigator.
- Normal G6PD enzyme activity levels as defined by the parameters of the specific G6PD test employed at the local laboratory.
- Negative HBsAg and HCV, HIV-1, HIV-2 antibody screen at the screening visit.
- Negative serum pregnancy test.
- Use acceptable method of birth control.
- 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.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Main
Exclusion
- History of allergy or intolerance to tafenoquine, primaquine or any excipients.
- History of thalassemia or current or past history of methemoglobinemia or methemoglobin \>2% at screening.
- History of eye disease or surgery
- 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.
- Any current diagnosis of Axis I psychiatric disorders
Key Trial Info
Start Date :
October 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2021
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03320174
Start Date
October 5 2017
End Date
July 13 2021
Last Update
August 26 2021
Active Locations (3)
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1
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States, 80909
2
Valley Retina Institute
McAllen, Texas, United States, 78503
3
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009