Escalating Monthly Doses of Tafenoquine in Healthy Volunteers

PHASE4UnknownINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

May 10, 2022

Primary Completion Date

December 3, 2022

Study Completion Date

December 3, 2022

Conditions
Prophylaxis
Interventions
DRUG

Tafenoquine prophylaxis

"The study will be conducted in three parts with 200 participants invited to participate in the study.~* Part 1 consist of 200 participants to be administered a loading dose of 600 mg tafenoquine (200 mg daily for 3 days) followed by 200 mg weekly for two weeks.~* Part 2: The same participants from Part 1 will be administered a monthly dose of tafenoquine (600 mg total, given as 300 mg split over 2 days) for two consecutive months. This monthly dose of 600 mg tafenoquine is designated the low monthly tafenoquine dose.~* Part 3: The same participants from Parts 1 and 2 will be administered a monthly dose of tafenoquine (800 mg total, given as 400 mg split over 2 days) for two consecutive months. This monthly dose of 800 mg tafenoquine is designated the high monthly tafenoquine dose."

Trial Locations (1)

10000

108 Military Central Hospital, Hanoi

Sponsors
All Listed Sponsors
collaborator

Naval Medical Research Unit TWO (NAMRU-2)

UNKNOWN

collaborator

Australian Defence Force Malaria and Infectious Disease Institute (ADF MIDI)

UNKNOWN

collaborator

The 108 Military Central Hospital

OTHER_GOV

collaborator

Naval Environmental Preventive Medicine Unit TWO (NEPMU-2)

UNKNOWN

lead

Naval Medical Research Center

FED

NCT05203744 - Escalating Monthly Doses of Tafenoquine in Healthy Volunteers | Biotech Hunter | Biotech Hunter