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Tafenoquine

Long-Term Safety Study of Tafenoquine

Ensayo de 60 DEGREES PHARMACEUTICALS, INC. en Voluntarios sanos.

Fase

Fase 2

Estado

Completado

Participantes

600

previstos

Centros

3

Fin del objetivo primario

jul 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2017.

Qué mide

Serious Ophthalmic Safety Event (After 12 months of exposure to study drug) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de SXTP

Todos los de SXTP, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03320174), actualizada en mar 2026.