Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01205178 | G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine) | PHASE1 | COMPLETED | 192 | — | — | Jul 2, 2009 | Apr 1, 2013 | Jun 7, 2017 | 2 | Thailand |
| NCT00871156 | Tafenoquine/Chloroquine DDI Study | PHASE1 | COMPLETED | 68 | — | — | Mar 24, 2009 | Aug 26, 2009 | Jun 19, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Tafenoquine | ACTIVE_COMPARATOR | Tafenoquine, TQ is an 8-aminoquinoline (8-AQ) antimalarial drug being developed for the radical cure of acute P. vivax malaria. Chloroquine will be given for the first 3 days in second and third part of this study to treat Malaria. |
| Chloroquine | ACTIVE_COMPARATOR | Dose for first 3 days for Part B \& C of the study |
| Primaquine | ACTIVE_COMPARATOR | once daily for first 14 days |
| Part 1 | ACTIVE_COMPARATOR | Tafenoquine + Chloroquine vs. Chloroquine alone |
| Part 2 | PLACEBO_COMPARATOR | Chloroquine alone, Tafenoquine alone or Chloroquine+Tafenoquine |
| Name | Type | Description |
|---|---|---|
| Chloroquine | DRUG | The current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ); typically 600 mg day 1, 600 mg day 2, 300 mg day 3 for clearance of the acute parasitemia. After this Tafenoquine will be given and subject will be followed up. |
| Primaquine | DRUG | Primaquine (PQ) is another 8 aminoquinoline drug available for Malaria treatment |
| Tafenoquine | DRUG | Once daily on Day 1 only. For Part B and C of this study Chloroquine will be given to treat Malaria |
| Chloroquine, Tafenoquine | DRUG | Chloroquine and Tafenoquine |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * A subject will be eligible for inclusion in this study only if all of the following criteria apply: * The subject is between 18 and 45 years of age, inclusive * A female is eligible to enter and participate in this study if she is non-pregnant, non-lactating and if she is of: ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 4 | PHASE3 | Tafenoquine, Primaquine, Chloroquine, GSK3772701, RTS,S/AS01E vaccine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |