The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to eliminate it. This study will involve a single dose of ¹⁴C radiolabelled LY3502970. This means that a radioactive substance will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to 8 weeks (maximum).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
Administered orally.
Covance Clinical Research
Leeds, United Kingdom
Feces Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Feces excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Feces samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome.
Time frame: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdose
Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Urinary excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Urine samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome.
Time frame: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve t, Where t is the Last Time Point With a Measurable Concentration (AUC0- Tlast) of Plasma LY3502970
PK: AUC0-tlast of plasma LY3502970
Time frame: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose
PK: Area Under the Concentration Versus Time Curve t, Where t is the Last Time Point With a Measurable Concentration ((AUC0- Tlast) of Total Radioactivity in Plasma and Whole Blood
PK: AUC0-tlast of total radioactivity in plasma and whole blood
Time frame: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose
PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Plasma LY3502970
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PK: AUC(0-∞) of plasma LY3502970
Time frame: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose
PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Total Radioactivity in Plasma and Whole Blood
PK: AUC(0-∞) of total radioactivity in plasma and whole blood
Time frame: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose
PK: Maximum Concentration (Cmax) of Plasma LY3502970
PK: Cmax of plasma LY3502970
Time frame: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose
PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood
PK: Cmax of total radioactivity in plasma and whole blood
Time frame: Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose
Total Number of Metabolites of LY3502970 in Plasma, Urine and Feces
* Total number of metabolites of LY3502970 in plasma, urine and feces samples pooled across participants to assess the presence of metabolites. * Urine and feces samples collected as a 12-hour predose interval (-12 to 0 hour \[h\], where 0h = time of dose administration) and then continuously postdose in specified intervals through 384h were used to assess this outcome. * Feces Sample collection time frame : -12 to 0, 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 336-360, 360-384h postdose
Time frame: Plasma: 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 h postdose; Urine: -12 to 0, 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 336-360, 360-384h postdose