Phase 1
Completed N=6
A Study of LY2940680 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01746745 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Fecal Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered — 82.7 percentage of dose administered
Summary
This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy participants to study how the body absorbs and removes LY2940680 from the blood. This study is for research purposes only and is not intended to treat any medical condition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fecal Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
82.7 | — |
| PRIMARY Urinary Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
14.6 | — |
| SECONDARY Plasma PK of LY2940680 and LSN3185556: Maximum Observed Concentration (Cmax) |
831; 1210 | — |
| SECONDARY PK of Radioactivity: Cmax |
2380; 1520 | — |
| SECONDARY PK of LY2940680, LSN3185556, and Radioactivity: Time of Maximum Observed Concentration (Tmax) |
1.51; 2.50; 2.00; 2.00 | — |
| SECONDARY Plasma PK of LY2940680 and LSN3185556: Area Under the Concentration-Time Curve From Time 0 to the Last Time Point With a Measurable Concentration [AUC(0 to Tlast)] |
5680; 20400 | — |
| SECONDARY PK of Radioactivity: AUC(0 to Tlast) |
64800; 38200 | — |
| SECONDARY Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Plasma |
11.1; 52.0; 17.1 | — |
| SECONDARY Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Urine |
0.105; 2.87; 1.82 | — |
| SECONDARY Relative Abundance of LY2940680, the Metabolites of LY2940680, and LSN3185556 in Feces |
0.431; 37.1; 3.04; 3.19; 2.90 | — |
Eligibility Criteria
Inclusion Criteria
- Generally healthy sterile males or surgically sterile females or postmenopausal females, as determined by medical history and laboratory assessments
- Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2), inclusive
Exclusion Criteria
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Have consumed herbal supplements, grapefruit juice, grapefruits, grapefruit containing products, Seville orange juice, Seville oranges, star fruit, or star fruit juice within 7 days prior to dosing or intend to consume during the study
- Have donated blood of more than 500 milliliters (mL) within the last month
- Have participated in a [^14C]-study within the last 6 months prior to admission for this study
- Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
- Have a pattern less than once per 2 days to expel feces from the bowel through the rectum or acute constipation within 3 weeks of the day prior to dose
Data sourced from ClinicalTrials.gov (NCT01746745). 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.