Phase 1
Completed N=72
A Study of LY3478045 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT04270370 ↗
Enrolled (actual)
72
Serious AEs
1.4%
Results posted
Jul 2024
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 participants
Summary
The main purpose of this study in healthy participants is to learn more about the safety of LY3478045 and any side effects that might be associated with it. The study will also measure how much LY3478045 gets into the bloodstream and how long it takes the body to get rid of it.
This study has two parts: Part A (one dose) will last about six weeks and Part B (more than one dose) will last about eight weeks for each participant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3478045 |
7410; 24300; 59900; 275000; 382000; 67800 | — |
| SECONDARY PK: Maximum Concentration (Cmax) of LY3478045 |
303; 1280; 3670; 14500; 18500; 2360 | — |
Eligibility Criteria
Inclusion Criteria
- Are overtly healthy participants as determined through medical history and physical examination
- Have a body mass index greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²)
- Have had a stable weight for 3 months prior to screening and enrollment (less than [ )160/90 millimeters of mercury (mmHg) and pulse rate 100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator
- Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 (CYP)3A or organic anion-transporting polypeptides (OATPs) are specifically excluded within 14 days prior to the first administration of study drug and during the study
Data sourced from ClinicalTrials.gov (NCT04270370). 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.