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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02751294 | A Study to Assess the Effects of Dissolution Profile on the Pharmacokinetics of Single Oral Doses of Tafenoquine Tablets and Tafenoquine Stable Isotope Labelled Solution | PHASE1 | COMPLETED | 14 | — | — | May 1, 2016 | Aug 1, 2016 | Jan 20, 2017 | 1 | United States |
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...