Phase 1
Completed N=6
A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01913314 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Urinary and Fecal Excretion of LY2835219-Related Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered — 3.43; 81.0 percentage radioactive dose administered
Summary
This type of study is called a radiolabeled study. For this study, LY2835219 (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 help understand how the drug appears in the blood, urine, and stool after it is administered.
In addition, this study will also evaluate the safety and tolerability of a single dose of LY2835219 when given to healthy participants. Information about any side effects that may occur will also be collected.
This study will last about 3 weeks for each participant, not including screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary and Fecal Excretion of LY2835219-Related Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
3.43; 81.0 | — |
| SECONDARY Plasma Pharmacokinetics (PK) of LY2835219 and Metabolite of LY2835219: Maximum Observed Concentration (Cmax) |
63.7; 30.9 | — |
| SECONDARY Plasma PK of Radioactivity: Cmax |
123 | — |
| SECONDARY Plasma PK of LY2835219, Metabolite of LY2835219, and Radioactivity: Time of Maximum Observed Concentration (Tmax) |
8.00; 8.00; 8.00 | — |
| SECONDARY Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration-Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC(0-tlast)] |
2310; 1760 | — |
| SECONDARY Plasma PK of Radioactivity: AUC(0 to Tlast) |
6580 | — |
| SECONDARY Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] |
2370; 1830 | — |
| SECONDARY Plasma PK of Radioactivity: AUC(0-∞) |
7010 | — |
| SECONDARY Relative Abundance of LY2835219 and Metabolites of LY2835219 Eliminated in Urine and Feces |
7; 52 | — |
| SECONDARY Relative Abundance of LY2835219 and Metabolites of LY2835219 in Plasma |
34; 44 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy male or female participants as determined by medical history and physical examination
- Male participants will be sterile
- Female participants will be surgically sterile or postmenopausal
- Have a body mass index (BMI) of 18 to 29 kilograms per square meter (kg/m^2)
- Have venous access sufficient to allow for blood sampling
Exclusion Criteria
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes
Data sourced from ClinicalTrials.gov (NCT01913314). 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.