Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Afuresertib GC · 1 trial · 1 indication
Relative bioavailability of afuresertib after single dose of a GC, HPMC capsule and ECT, with and without high fat/calorie meal, will be determined by the following PK parameters: Area under the plasma concentration time curve- from time zero (pre-dose) to infinite time \[AUC(0-inf)\] and from time zero (pre-dose) to last time of quantifiable concentration \[AUC(0-t)\], maximum observed plasma concentration (Cmax), time to Cmax (tmax), observed plasma concentration at 24 hours (C24), and minimal observed plasma concentration (Ct)
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Subjects will receive single doses of AFU HPMC capsule administered in a fasted state, AFU ECT administered in a fasted state, AFU HPMC capsule administered in a fed state and AFU GC administered in a fasted state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period |
| Sequence 2 | EXPERIMENTAL | Subjects will receive single doses of AFU ECT administered in a fasted state, AFU ECT administered in a fed state, AFU GC administered in a fasted state and AFU GC administered in a fed state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period. |
| Sequence 3 | EXPERIMENTAL | Subjects will receive single doses of AFU GC administered in a fasted state, AFU GC administered in a fed state, AFU ECT administered in a fed state and AFU HPMC capsule administered in a fasted state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period. |
| Sequence 4 | EXPERIMENTAL | Subjects will receive single doses of AFU GC administered in a fed state, AFU HPMC capsule administered in a fed state, AFU HPMC capsule administered in a fasted state and AFU ECT administered in a fasted state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period |
| Sequence 5 | EXPERIMENTAL | Subjects will receive single doses of AFU ECT administered in a fed state, AFU HPMC capsule administered in a fasted state, AFU GC administered in a fed state and AFU HPMC capsule administered in a fed state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period |
| Sequence 6 | EXPERIMENTAL | Subjects will receive single doses of AFU HPMC capsule administered in a fed state, AFU GC administered in a fasted state, AFU ECT administered in a fasted state and AFU ECT administered in a fed state (sequentially), on Day 1 of Dosing Period 1, 2, 3 and 4 (one treatment per period) respectively, with a minimum 10 Day washout between the doses in each Dosing Period |
| Name | Type | Description |
|---|---|---|
| Afuresertib GC - Fasted State | DRUG | White opaque hard gelatin capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib GC administered in fasted state |
| Afuresertib HPMC capsule - Fasted State | DRUG | White opaque HPMC capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib HPMC capsule administered in fasted state |
| Afuresertib ECT - Fasted State | DRUG | White to off white, round, biconvex coated tablet containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib ECT administered in fasted state |
| Afuresertib GC - Fed State | DRUG | White opaque hard gelatin capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib GC administered in fed state |
| Afuresertib HPMC capsule - Fed State | DRUG | White opaque HPMC capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib HPMC capsule administered in fed state |
| Afuresertib ECT - Fed State | DRUG | White to off white, round, biconvex coated tablet containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib ECT administered in fed state |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Male or female between 18 and 40 years of age inclusive, at the time of signing the infor...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
Afuresertib GC is an investigational small molecule developed by GSK plc for cancer. It is a Phase 1 drug candidate studied in a bioavailability and food effect trial in healthy volunteers. It is not approved and remains in clinical development.
Afuresertib GC targets AKT1, AKT2, and AKT3. It is an inhibitor of these AKT kinases, which are part of the PI3K/AKT signaling pathway involved in cell growth and survival. Targeting AKT is being explored as an approach in oncology.
Afuresertib GC is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this investigational AKT inhibitor in cancer.
Afuresertib GC is in Phase 1 development. It is investigational and has not been approved for any indication. The Phase 1 program has completed one trial, and no active trials are currently listed.
Afuresertib GC has been studied in NCT01827644, a completed Phase 1 bioavailability and food effect trial of the original gelatin formulation and two new formulations. The trial enrolled 36 healthy volunteers in Australia and included a controlled, randomized design.
Yes. Afuresertib GC is also referred to as Afuresertib GC Fasted State, Afuresertib GC Fed State, and variants with a hyphen. These names describe the fasting and fed conditions used in the bioavailability and food effect study of the same drug.