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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06102512 | A Study of [14C]-LOXO-783 in Healthy Adult Participants | PHASE1 | COMPLETED | 16 | — | — | Oct 23, 2023 | Jan 17, 2024 | Jul 22, 2024 | 1 | United States |
| NCT06028425 | A Study to Evaluate the Effect of Food on LOXO-783 in Healthy Participants | PHASE1 | COMPLETED | 42 | — | — | Sep 1, 2023 | Dec 23, 2023 | Jul 22, 2024 | 1 | United States |
| NCT05894928 | A Study to Evaluate the Effect of Cholestyramine on LOXO-783 in Healthy Participants | PHASE1 | COMPLETED | 21 | — | — | Jun 7, 2023 | Jul 9, 2023 | Sep 26, 2023 | 1 | United States |
PK: Feur
PK: Fefeces
PK: Feair
PK: F of LOXO-783
PK: Cmax of LOXO-783
PK: AUC \[0-∞\] of LOXO-783
PK: AUC(0-inf) of LOXO-783
| Arm | Type | Description |
|---|---|---|
| [¹⁴C]-LOXO-783 (Part 1) | EXPERIMENTAL | Single dose of \[¹⁴C\]-LOXO-783 administered orally |
| LOXO-783 + [¹⁴C]-LOXO-783 (Part 2) | EXPERIMENTAL | Single dose of LOXO-783 administered orally followed by single dose of \[¹⁴C\]-LOXO-783 administered intravenously (IV) |
| LOXO-783 (Fasted State) | EXPERIMENTAL | LOXO-783 administered orally to participants who are in fasted state |
| LOXO-783 (Fed State - Low Fat Meal) | EXPERIMENTAL | LOXO-783 administered orally to participants who are on low fat meal |
| LOXO-783 (Fed State - High Fat Meal) | EXPERIMENTAL | LOXO-783 administered orally to participants who are on high fat meal |
| LOXO-783 alone | EXPERIMENTAL | Single dose of LOXO-783 administered orally. |
| LOXO-783 + Cholestyramine 1 hour post dose | EXPERIMENTAL | Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 1 hour. |
| LOXO-783 + Cholestyramine 4 hours post dose | EXPERIMENTAL | Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 4 hours. |
| Name | Type | Description |
|---|---|---|
| [¹⁴C]-LOXO-783 | DRUG | Administered orally |
| LOXO-783 | DRUG | Administered orally |
| Cholestyramine | DRUG | Administered orally. |
Inclusion Criteria: * Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination, ECGs, vital signs, and clinical laboratory evaluations as assessed by the investigator * Have a body mass index within the range 18.5 to 32...