The goal of the study is to learn what happens to different forms of TERN-701 medications in a healthy person's body over time. Researchers will compare what happens to different forms of TERN-701 in a person's body over time. The goal of the study is to learn: * What happens to different forms of TERN-701 in a person's body over time. * The amount and number of different forms of TERN-701 that leave a person's body over time.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Oral Liquid radiolabeled with \[14C\]-TERN-701
Pharmaron CPC Inc
Baltimore, Maryland, United States
Percentage of Total Amount of [14C]-Radiolabel Excreted into Urine per Sampling Interval (Aeurine,14C,t1-t2)
Urine will be collected to determine the Aeurine,14C,t1-t2 of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Cumulative Percentage of Total Amount of [14C]-Radiolabel Excreted into Urine up to the Last Sampling Interval (Aeurine,14C)
Urine will be collected to determine the Aeurine,14C of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Percentage of Total Amount of [14C]-Radiolabel Excreted into Feces per Sampling Interval (Aefeces,14C,t1-t2)
Feces will be collected to determine the Aefeces,14C,t1-t2 of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Cumulative Percentage of Total Amount of [14C]-Radiolabel Excreted into Feces Up to the Last Sampling Interval (Aefeces,14C)
Feces will be collected to determine the Aefeces,14C of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Percentage of Total Amount of [14C]-Radiolabel Excreted from Body per Sampling Interval (Aetotal, 14C, t1-t2)
Urine and Feces will be collected to determine the Aetotal,14C,t1-t2 of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Cumulative Percentage of Total Excretion of [14C]-Radiolabel from the Body (Aetotal, 14C)
Urine and Feces will be collected to determine the Aetotal,14C of radiolabeled \[14C\]-TERN-701. Calculated as, Aetotal,14C= Aeurine,14C +Aefeces,14C.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Maximum Concentration Observed in Plasma (Cmax) of TERN-701 in Plasma
Blood samples will be collected to determine the Cmax of TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Time to Maximum Concentration Observed in Plasma (Tmax) of TERN-701 in Plasma
Blood samples will be collected to determine the Tmax of TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Apparent Terminal Half-Life (t1/2) of TERN-701 in Plasma
Blood samples will be collected to determine the t1/2 of TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Area Under the Concentration-Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of TERN-701 in Plasma
Blood samples will be collected to determine the AUC0-Last of TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-Inf) of TERN-701 in Plasma
Blood samples will be collected to determine the AUC0-inf of TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Apparent Oral Clearance (CL/F) of TERN-701 in Plasma
Blood samples will be collected to determine the CL/F of TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Apparent Volume of Distribution (Vz/F) of TERN-701 in Plasma
Blood samples will be collected to determine the Vz/F of TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Total [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the Total \[14C\]-Radiolabel, calculated as the AUCinf of non-radiolabeled TERN-701 in plasma divided by the AUCinf of total \[14C\]-radiolabel in plasma.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Tmax of Total [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the Tmax of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
t1/2 of Total [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the t1/2 of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
AUC0-last of Total [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the AUC0-last of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
AUC0-Inf of Total [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the AUC0-Inf of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Cmax of Total [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the Cmax of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Tmax of Total [14C]-Radiolabel in Whole Blood
Blood samples will be collected to determine the Tmax of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
t1/2 of Total [14C]-Radiolabel in Whole Blood
Blood samples will be collected to determine the t1/2 of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
AUC0-last of Total [14C]-Radiolabel in Whole Blood
Blood samples will be collected to determine the AUC0-last of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
AUC0-Inf of Total [14C]-Radiolabel in Whole Blood
Blood samples will be collected to determine the AUC0-Inf of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Cmax of Total [14C]-Radiolabel in Whole Blood
Blood samples will be collected to determine the Cmax of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Cumulative Amount of Total [14C]-Radiolabel Excreted in Urine (Aeurine)
Urine samples will be collected to determine the Aeurine of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Renal Clearence (CLr) of [14C] radioactivity
Urine samples will be collected to determine the CLr of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Percent of Dose Excreted as Radioactivity in Urine (%Feurine) of [14C] radioactivity
Urine samples will be collected to determine the %Feurine of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Cumulative Amount of Total [14C]-Radiolabel Excreted in Feces (Aefeces) of [14C] radioactivity
Feces samples will be collected to determine the Aefeces of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Percent of Dose Excreted as Radioactivity in Feces (%Fefeces) of [14C] radioactivity
Feces samples will be collected to determine the %Fefeces of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Percentage Area Under the Concentration-Time Curve (AUC) of [14C]-Radiolabel TERN-701 Metabolite in Plasma
Blood samples will be collected to determine the Percentage of AUC of \[14C\]-radiolabel TERN-701 metabolite in plasma.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Percentage of Administered Dose of [14C]-Radiolabel TERN-701 Metabolite in Feces
Feces samples will be collected to determine the percentage of administered dose of \[14C\]-radiolabel TERN-701 metabolite in feces.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Percentage of the [14C]-Radiolabel TERN-701 Metabolite in Urine
Urine samples will be collected to determine the percentage of \[14C\]-radiolabel TERN-701 metabolite in urine.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Mean concentration of [14C]-TERN-701 Elimination
Blood, Feces, and Urine samples will be collected to determine the mean concentration of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Rate of Elimination of [14C]-TERN-701
Blood, Feces, and Urine samples will be collected to determine the Rate of Elimination of radiolabeled \[14C\]-TERN-701.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Whole Blood to Plasma Total [14C]-Radiolabel AUC Ratio
Blood samples will be collected to determine the Whole Blood to Plasma AUC Ratio. Calculated as AUC0-Inf of total \[14C\]-radiolabel in whole blood divided by the AUC0-Inf of Total \[14C\]-Radiolabel in Plasma.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Number of TERN-701 Metabolite in ≥10% of Total Exposure of [14C]-Radiolabel in Plasma
Blood samples will be collected to determine the number of TERN-701 metabolite that account for ≥10% of total drug-related radiolabeled \[14C\]-TERN-701 exposure in plasma.
Time frame: Pre-dose and at designated time points up to 408 hours post dose
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 49 days
Number of Participants Who Discontinue Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.
Time frame: Up to approximately 18 days