Phase 1
Completed N=16
A Study of LY2409021 in Healthy Participants
Healthy Participants
Source: ClinicalTrials.gov NCT02217618 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 — 48100 nanogram*hours per milliliter (ng*h/mL)
Summary
The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of the drug after the dose. This study will last approximately 28 days, not including screening. Screening can occur within 30 days prior to the start of the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 |
48100 | — |
| PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 |
625 | — |
| PRIMARY Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021 |
8.00 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy males or females as determined by medical history
- Satisfactory clinical laboratory and physical examination tests
- Have a body mass index (BMI) of 18 to 32.0 kilograms per meter squared (kg/m^2)
Exclusion Criteria
- Abnormal electrocardiograms (ECGs)
Data sourced from ClinicalTrials.gov (NCT02217618). 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.