Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in the Treatment of Subjects With Plasmodium Vivax Malaria
Brief Summary: This is a prospective, double-blind, double-dummy, multicenter, comparative study. A total of 300 subjects will be randomized to treatment on Day 1, of which a minimum of 50 female subjects must be enrolled that display moderate glucose-6-phosphate dehydrogenase (G6PD) deficiency (\>=40% - \<70% of the site median G6PD value). Subjects must have a blood smear that is positive for P. vivax at entry. Subjects will be randomized 2:1 to receive tafenoquine (TQ)/chloroquine(CQ) or the active comparator primaquine (PQ)/CQ. All subjects will receive CQ on Days 1 to 3, followed by TQ or PQ and matching placebo beginning on Day 1 or 2. Tafenoquine, or matching placebo, will be given as a single, 300mg dose. Subjects will receive PQ (15mg once daily) or matching placebo for 14 days. The duration of the study is 180 days, including screening and randomization to treatment (Day 1), three in-hospital days (Days 1-3), four out-patient visits while on treatment with study medication (Days 5, 8, 11 and 15) and seven follow-up visits (Days 22, 29, 60, 90, 120, 150 and 180).

The primary safety data collected in this study will help to understand the hemolysis risk to both G6PD-normal and G6PD-deficient subjects. The efficacy data produced from this study will support the results for sister study TAF112582, the pivotal phase III efficacy and safety study of the TQ program.


Options:
A: Arm Label: Tafenoquine 50mg; Type: EXPERIMENTAL; Interventions: Drug: Chloroquine 600mg, Drug: Chloroquine 300mg, Drug: Tafenoquine 50mg | Arm Label: Tafenoquine 100mg; Type: EXPERIMENTAL; Interventions: Drug: Chloroquine 600mg, Drug: Chloroquine 300mg, Drug: Tafenoquine 100mg | Arm Label: Tafenoquine 300mg; Type: EXPERIMENTAL; Interventions: Drug: Chloroquine 600mg, Drug: Chloroquine 300mg, Drug: Tafenoquine 300mg | Arm Label: Tafenoquine 600mg; Type: EXPERIMENTAL; Interventions: Drug: Chloroquine 600mg, Drug: Chloroquine 300mg, Drug: Tafenoquine 600mg | Arm Label: Primaquine 15mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Chloroquine 600mg, Drug: Chloroquine 300mg, Drug: Primaquine 15mg | Arm Label: Chloroquine only; Type: PLACEBO_COMPARATOR; Interventions: Drug: Chloroquine 600mg, Drug: Chloroquine 300mg | Arm Label: Tafenoquine 300mg (Part 2); Type: EXPERIMENTAL; Interventions: Drug: Chloroquine 600mg (Part 2 ), Drug: Chloroquine 300mg (Part 2 ), Drug: Tafenoquine 300mg (Part 2) | Arm Label: Primaquine 15mg (Part 2); Type: ACTIVE_COMPARATOR; Interventions: Drug: Chloroquine 600mg (Part 2 ), Drug: Chloroquine 300mg (Part 2 ), Drug: Primaquine 15mg (Part2 ) | Arm Label: Chloroquine only (Part 2); Type: PLACEBO_COMPARATOR; Interventions: Drug: Chloroquine 600mg (Part 2 ), Drug: Chloroquine 300mg (Part 2 ) | Intervention Type: DRUG; Name: Chloroquine 600mg; Assigned to Arm(s): Chloroquine only, Primaquine 15mg, Tafenoquine 100mg, Tafenoquine 300mg, Tafenoquine 50mg, Tafenoquine 600mg | Intervention Type: DRUG; Name: Chloroquine 300mg; Assigned to Arm(s): Chloroquine only, Primaquine 15mg, Tafenoquine 100mg, Tafenoquine 300mg, Tafenoquine 50mg, Tafenoquine 600mg | Intervention Type: DRUG; Name: Tafenoquine 50mg; Assigned to Arm(s): Tafenoquine 50mg | Intervention Type: DRUG; Name: Tafenoquine 100mg; Assigned to Arm(s): Tafenoquine 100mg | Intervention Type: DRUG; Name: Tafenoquine 300mg; Assigned to Arm(s): Tafenoquine 300mg | Intervention Type: DRUG; Name: Tafenoquine 600mg; Assigned to Arm(s): Tafenoquine 600mg | Intervention Type: DRUG; Name: Primaquine 15mg; Assigned to Arm(s): Primaquine 15mg | Intervention Type: DRUG; Name: Chloroquine 600mg (Part 2 ); Assigned to Arm(s): Chloroquine only (Part 2), Primaquine 15mg (Part 2), Tafenoquine 300mg (Part 2) | Intervention Type: DRUG; Name: Chloroquine 300mg (Part 2 ); Assigned to Arm(s): Chloroquine only (Part 2), Primaquine 15mg (Part 2), Tafenoquine 300mg (Part 2) | Intervention Type: DRUG; Name: Tafenoquine 300mg (Part 2); Assigned to Arm(s): Tafenoquine 300mg (Part 2) | Intervention Type: DRUG; Name: Primaquine 15mg (Part2 ); Assigned to Arm(s): Primaquine 15mg (Part 2)
B: Arm Label: Cohort 1 Tafenoquine; Type: EXPERIMENTAL; Interventions: Drug: Tafenoquine | Arm Label: Cohort 1-Chloroquine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Chloroquine + Primaquine | Arm Label: Cohort 2 Tafenoquine; Type: EXPERIMENTAL; Interventions: Drug: tafenoquine | Arm Label: Cohort 2 Chloroquine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Chloroquine + Primaquine | Intervention Type: DRUG; Name: Tafenoquine; Assigned to Arm(s): Cohort 1 Tafenoquine | Intervention Type: DRUG; Name: Chloroquine + Primaquine; Assigned to Arm(s): Cohort 1-Chloroquine | Intervention Type: DRUG; Name: tafenoquine; Assigned to Arm(s): Cohort 2 Tafenoquine | Intervention Type: DRUG; Name: Chloroquine + Primaquine; Assigned to Arm(s): Cohort 2 Chloroquine
C: Arm Label: Tafenoquine 300 milligram (mg) single dose; Type: EXPERIMENTAL; Interventions: Drug: Tafenoquine 150 mg | Arm Label: Matched Placebo 300mg single dose; Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched placebo 150mg | Intervention Type: DRUG; Name: Tafenoquine 150 mg; Assigned to Arm(s): Tafenoquine 300 milligram (mg) single dose | Intervention Type: DRUG; Name: Matched placebo 150mg; Assigned to Arm(s): Matched Placebo 300mg single dose
D: Arm Label: Tafenoquine+ Chloroquine; Type: EXPERIMENTAL; Interventions: Drug: Tafenoquine, Drug: Chloroquine, Drug: Primaquine Placebo | Arm Label: Primaquine+ Chloroquine; Type: EXPERIMENTAL; Interventions: Drug: Tafenoquine Placebo, Drug: Chloroquine, Drug: Primaquine | Intervention Type: DRUG; Name: Tafenoquine; Assigned to Arm(s): Tafenoquine+ Chloroquine | Intervention Type: DRUG; Name: Tafenoquine Placebo; Assigned to Arm(s): Primaquine+ Chloroquine | Intervention Type: DRUG; Name: Chloroquine; Assigned to Arm(s): Primaquine+ Chloroquine, Tafenoquine+ Chloroquine | Intervention Type: DRUG; Name: Primaquine; Assigned to Arm(s): Primaquine+ Chloroquine | Intervention Type: DRUG; Name: Primaquine Placebo; Assigned to Arm(s): Tafenoquine+ Chloroquine

Answer: D