Approval Probability
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LY3039478 Formulation · 3 trials · 1 indication
Pharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3039478 and 13C 15N 2H-LY3039478.
PK is AUC from zero to infinity (AUC\[0 - inf\]) of LY3039478 and 13C 15N 2H-LY3039478.
To determine the disposition of radioactivity and LY3039478 in healthy participants following oral administration of a single dose 14C-labeled LY3039478.
PK: mean time-matched difference in QTcF interval with time-matched concentrations between LY3039478 capsule formulation (formulation 3) compared to placebo. Analyses of QTcF was assessed by the mean change in QTcF as a function of plasma drug concentration. Triplicate measures at each time point was averaged prior to analysis. The primary analysis was based on the time-matched placebo-adjusted QTcF (ΔQTcF) for each time point, which was calculated by subtracting each participant's time-matched placebo QTcF from their QTcF results after receiving LY3039478. The relationship between plasma concentrations of LY3039478 and ΔQTcF was evaluated using a linear mixed-effects modeling approach. The response variable was ΔQTcF, and concentrations was fitted as a fixed effect with participants as a random effect. The regression slope was presented with the unit in "milliseconds per nanogram per milliliter" abbreviated as "ms/ng/mL".
| Arm | Type | Description |
|---|---|---|
| LY3039478 - Oral | EXPERIMENTAL | LY3039478 given once, orally |
| 13C 15N 2H-LY3039478 - IV | EXPERIMENTAL | 13C 15N 2H-LY3039478 given once, IV |
| Radiolabelled LY3039478 | EXPERIMENTAL | Single dose of radiolabelled LY3039478 administered orally. |
| Part A: Placebo | PLACEBO_COMPARATOR | Single oral dose of placebo administered in one of three study periods |
| Part A: LY3039478 Capsule Formulation (Formulation 3) | EXPERIMENTAL | Escalating single oral dose of 25 milligram (mg), 50 mg, and 75 mg capsule formulation (formulation 3) LY3039478 administered in two of three study periods |
| Part B: LY3039478 Drug-In Capsule (Reference, Formulation 1) | EXPERIMENTAL | Single oral 50 mg dose of drug-in capsule (reference, formulation 1) LY3039478 administered in one of two study periods |
| Part B: LY3039478 Formulated Capsule (Test, Formulation 3) | EXPERIMENTAL | Single oral 50 mg dose of formulated capsule (test, formulation 3) LY3039478 administered in one of two study periods |
| Name | Type | Description |
|---|---|---|
| LY3039478 | DRUG | Administered orally |
| 13C 15N 2H-LY3039478 IV | DRUG | Administered IV |
| Placebo | DRUG | Administered orally |
| LY3039478 Capsule Formulation (Formulation 3) | DRUG | Administered orally |
| LY3039478 Drug-in Capsule (Reference, Formulation 1) | DRUG | Administered orally |
| LY3039478 Formulated Capsule (Test, Formulation 3) | DRUG | Administered orally |
Inclusion Criteria: \- Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive Exclusion Criteria: \- Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product • Hav...
LY3039478 is an investigational small molecule being studied for use in oncology. It has been evaluated in clinical trials for advanced solid tumors, neoplasms, lymphoma, and T-cell acute lymphoblastic leukemia. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
LY3039478 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical trials and remains investigational.
LY3039478 is in Phase 1 clinical development. All three clinical trials for the drug have been completed. It is an investigational agent and has not received regulatory approval for any indication.
LY3039478 has been studied in three completed Phase 1 trials. NCT01695005 evaluated the drug in 247 participants with advanced cancer. NCT02659865 and NCT02906618 studied it in healthy participants, and NCT02917733 examined its absorption, distribution, metabolism, and excretion in healthy participants.
LY3039478 is the primary identifier for this investigational compound. No alternative names for the drug have been disclosed in the clinical trial records. It is a small molecule being developed by Eli Lilly and Company for oncology indications.