Phase 1
Completed N=6
A Study of How the Body Breaks Down and Eliminates LY2623091
Healthy Volunteers
Source: ClinicalTrials.gov NCT02242981 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered — 60.5; 1.39 percentage of radioactive dose recovered
Summary
This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally occurring radioactive form of the element, carbon. This study will increase understanding about how the drug appears in the blood, urine, and stool after it is administered to healthy participants. Information about any side effects that may occur will also be collected. This study will last up to 22 days for each participant, not including screening. Screening is required within 28 days prior to enrollment
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
60.5; 1.39 | — |
| SECONDARY Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091 |
11800 | — |
| SECONDARY Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091 |
11800 | — |
| SECONDARY Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091 |
482 | — |
| SECONDARY Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces |
7; NA; 17 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy males; as determined by physical examination, clinical laboratory tests, medical history and electrocardiograms (ECGs).
- With a body mass index of 18.5 to 32.0 kilogram per square meter (kg/m^2), inclusive.
Exclusion Criteria
Data sourced from ClinicalTrials.gov (NCT02242981). 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.