Trial | NCT02491606  Report issue

Title

Evaluation of Weekly Tafenoquine
Evaluation of Weekly Tafenoquine (SB 252263 / WR 238605) Compared to Placebo for Chemosuppression of Plasmodium Falciparum in Western Kenya

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    249
This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR 238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum malaria in Nyanza Province, western Kenya.
Study Started
May 31
1997
Primary Completion
Sep 30
1997
Study Completion
Sep 30
1998
Last Update
Sep 13
2018

Drug Tafenoquine

Tafenoquine 200mg and 400 mg

Other Placebo

Placebo

Load only Experimental

Loading with tafenoquine 400 mg base for three days followed by placebo weekly.

Low weekly dose Experimental

Loading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly.

High weekly dose Experimental

Loading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly.

Placebo Experimental

Loading with placebo for 3 days followed by placebo once weekly.

Criteria 

Inclusion Criteria:

Healthy subjects (male or female)
Age of 18-55 years
Residing in one of the study villages of the Nyanza Province for the entire study

Exclusion Criteria:

Any cardiovascular, liver, neurologic, or renal functional abnormality which in the opinion of the clinical investigators would place the subject at increased risk of an adverse event or confuse the result.
Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).
Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.
Clinically significant abnormalities (including but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and complete blood count.
Known hypersensitivity to any study drug.
Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.
Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.
No Results Posted