Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tafenoquine Control · 1 trial · 1 indication
Blood samples for PK analysis of TQ will be collected for evaluation of ratio of the geometric means (90% Confidence Interval \[CI\]) for the area under plasma concentration-time curve from 0 to time t (AUC \[0-t\]) and area under the concentration-time curve from 0 to infinity (AUC\[0-inf\]) for the treatment group dissolution profile X compared to Control.
| Arm | Type | Description |
|---|---|---|
| TQ Control+ TQ SIL | EXPERIMENTAL | Subjects received TQ Control product (2 tablets) and 30 mg TQ SIL solution orally with water after a meal. |
| TQ X + TQ SIL | EXPERIMENTAL | Subjects received 2 tablets of Tafenoquine dissolution profile X and 30 mg TQ SIL solution orally with water after a meal. |
| Name | Type | Description |
|---|---|---|
| Tafenoquine Control | DRUG | It will be supplied as a dark pink, capsule-shaped, film-coated tablet plain on both sides containing 150 mg tafenoquine |
| Tafenoquine dissolution profile X | DRUG | It will be supplied as a dark pink, capsule-shaped, film-coated tablet plain on both sides containing 150 mg tafenoquine and will be "intermediate aged TQ Product". |
| Tafenoquine SIL | DRUG | It will be compounded at site and will be administered as 0.3 mg/mL (100mL to be dosed, equivalent to 30 mg) aqueous Solution of SIL Tafenoquine. |
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: * Between 18 and 55 years of age inclusive, at the time of signing the informed consent * Healthy as determined by the investigator or medically qualified designee based on a med...
Tafenoquine Control is an investigational small molecule being studied for vivax malaria, a form of malaria caused by the Plasmodium vivax parasite. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Tafenoquine Control is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The drug is in Phase 1 clinical development for vivax malaria.
Tafenoquine Control is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed, and the drug is not currently in active clinical trials.
Tafenoquine Control has one completed Phase 1 trial, NCT02751294, which assessed the effects of dissolution profile on the pharmacokinetics of single oral doses of tafenoquine tablets and a stable isotope labelled solution. The trial enrolled 14 healthy male volunteers in the United States.
Tafenoquine Control is a formulation of tafenoquine, an antimalarial drug. The 'Control' designation refers to a specific version used in clinical studies. It is being studied for vivax malaria and is in Phase 1 development.