| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02906618 | Study of LY3039478 in Healthy Participants | PHASE1 | COMPLETED | 12 | — | — | Oct 4, 2016 | Nov 11, 2016 | Jul 9, 2025 | 1 | United Kingdom |
| NCT02917733 | A Study of the Absorption, Distribution, Metabolism and Excretion of LY3039478 in Healthy Participants | PHASE1 | COMPLETED | 6 | — | — | Sep 1, 2016 | Nov 1, 2016 | Jul 28, 2025 | 1 | United States |
| NCT02659865 | A Study of LY3039478 in Healthy Participants | PHASE1 | COMPLETED | 29 | — | — | Jan 1, 2016 | Jun 1, 2016 | Aug 12, 2025 | 1 | United States |
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...