Long-Term Safety Study of Tafenoquine

Phase 2CompletedNCT03320174

60 Degrees Pharmaceuticals LLC600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

600

Conditions

Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Retina Consultants of Southern Colorado

Colorado Springs, Colorado, United States

Valley Retina Institute

McAllen, Texas, United States

Linear Clinical Research

Nedlands, Western Australia, Australia

Outcomes

Primary Outcomes

Serious Ophthalmic Safety Event

Number of Participants with One or More protocol-defined serious ophthalmic safety event (SOSE) assessed by retinal changes from baseline using SD-OCT and qFAF. SOSE is assessed by significant retinal changes from baseline using SD-OCT and qFAF.