Long-Term Safety Study of Tafenoquine
Status: | Recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 1/13/2019 |
Start Date: | October 5, 2017 |
End Date: | October 2020 |
Single Site, Randomized, Double Blind, Placebo-Controlled Study to Assess the Long-Term Safety of Tafenoquine
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 randomized (ratio 1:1) to receive a loading dose of either
tafenoquine 200 mg (2 x 100 mg tablets) or placebo daily for three consecutive days, followed
by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks, with safety
follow-up visits at Weeks 4, 12, 24, and 52. All participants will return to the clinic at
Week 64 for an end of study visit. If the participant has an ongoing AE at the Week 64 visit
will continue to be assessed for up to 3 more times at approximately 12-week intervals or
until resolution or stabilization of the AE whichever is earlier.
(Glucose-6-Phosphate Dehydrogenase [G6PD] normal) volunteers. Participants who meet the
eligibility criteria will be randomized (ratio 1:1) to receive a loading dose of either
tafenoquine 200 mg (2 x 100 mg tablets) or placebo daily for three consecutive days, followed
by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks, with safety
follow-up visits at Weeks 4, 12, 24, and 52. All participants will return to the clinic at
Week 64 for an end of study visit. If the participant has an ongoing AE at the Week 64 visit
will continue to be assessed for up to 3 more times at approximately 12-week intervals or
until resolution or stabilization of the AE whichever is earlier.
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
We found this trial at
3
sites
Nedlands, Western Australia 6009
Principal Investigator: Fred Chen, PhD, FRANZCO
Phone: 1300 546 327
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Colorado Springs, Colorado
Principal Investigator: Mark Chittum, MD
Phone: 719-473-9595
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McAllen, Texas 78503
Principal Investigator: Victor Gonzalez, MD
Phone: 956-631-8875
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