Long-Term Safety Study of Tafenoquine

60 Degrees Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Healthy Volunteers

Treatments: Other: Placebo; Drug: Tafenoquine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03320174

60PH04

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Tafenoquine 200 mg (2 x 100 mg tablets)

Active Comparator group

Description:

Tafenoquine 200 mg (2 x 100 mg tablets) daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks

Treatment:

Drug: Tafenoquine

Placebo

Placebo Comparator group

Description:

Placebo daily for three consecutive days, followed by study treatment (tafenoquine 200 mg or placebo) once per week for 51 weeks

Treatment:

Other: Placebo