Phase 1
Completed N=12
Study of LY3039478 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02906618 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Pharmacokinetics (PK): 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 — 1920; 15.6 nangogram*hour/milliliter (ng*h/mL)
Summary
The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions:
* How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV
* How long it takes the body to remove the study drug
* The safety of LY3039478 and any side effects that might be associated with it
Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): 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 |
1920; 15.6 | — |
| PRIMARY PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478 |
1920; 15.6 | — |
| SECONDARY PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV |
444; 7.24 | — |
| SECONDARY PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478 |
1.500; 0.750 | — |
| SECONDARY PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478 |
5.42; 3.31 | — |
Eligibility Criteria
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- Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product
- Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator
Data sourced from ClinicalTrials.gov (NCT02906618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.