This open-label study is being conducted to determine the metabolism and physiological disposition of radiolabeled LY2886721 after a single dose in healthy male participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
Administered orally
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madison, Wisconsin, United States
Percentage of Urinary and Fecal Excretion of LY2886721 Radioactivity Over Time
Urinary and fecal excretion of LY2886721 radioactivity over time was expressed as a percentage of the total radioactive dose administered. The amount of drug-related material excreted in urine and feces (Ae) at a specific collection interval (i) was calculated as the product of radioactivity concentration and volume or weight. The Ae values for each collection interval were then summed and calculated as Total Ae=Ae(i1)+Ae(i2)+Ae(in). The percentage of the total radiolabeled dose administered that was excreted in feces or urine=\[(Total Ae)/(Total radioactive dose administered)\]\*100.
Time frame: Predose up to 7 days (168 hours) postdose
Plasma Pharmacokinetics (PK) of LY2886721: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0 to Inf)]
Time frame: Predose up to 4 days (96 hours) postdose
PK of Radioactivity: AUC(0 to Inf)
AUC(0 to inf) for plasma and whole blood total radioactivity is reported as hours\*nanogram equivalents per milliliter (h\*ng Eq/mL).
Time frame: Predose up to 4 days (96 hours) postdose
Plasma PK of LY2886721: Maximum Observed Concentration (Cmax)
Time frame: Predose up to 4 days (96 hours) postdose
PK of Radioactivity: Cmax
The Cmax of total radioactivity in plasma and whole blood are reported as nanogram equivalents per milliliter (ng Eq/mL).
Time frame: Predose up to 4 days (96 hours) postdose
Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Plasma
The metabolites of LY2886721 were identified using a high performance liquid chromatography (HPLC) chromatogram. The relative abundance of LY2886721 and its metabolites in plasma were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100. Radioactivity corresponds to 80 μCi \[\^14C\]-LY2886721.
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Time frame: 1 to 8 hours postdose
Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Urine
The metabolites of LY2886721 were identified using an HPLC chromatogram. The relative abundance of LY2886721 and its metabolites in urine were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100. Radioactivity corresponds to 80 μCi \[\^14C\]-LY2886721.
Time frame: 0 to 72 hours postdose
Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Feces
The metabolites of LY2886721 were identified using an HPLC chromatogram. The relative abundance of LY2886721 and its metabolites in feces were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100. Radioactivity corresponds to 80 μCi \[\^14C\]-LY2886721.
Time frame: 0 to 144 hours postdose