Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SYR-322MET · 1 trial · 1 indication
AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.
AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC \[0-tlqc\]).
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr).
Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC \[0-inf\]) divided by AUC (0-inf). (AUMC \[0-inf\]) is the area under the first moment plasma concentration-time curve from time 0 to infinity.
MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.
AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.
AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC \[0-tlqc\]).
MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC \[0-inf\]) divided by AUC (0-inf). AUMC (0-inf) is the area under the first moment plasma concentration-time curve from time 0 to infinity.
AUC (0-48) is measure of area under the curve from time 0 to 48 hours post dose.
AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC \[0-tlqc\]).
MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in L/hr.
Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC \[0-inf\]) divided by AUC (0-inf). AUMC (0-inf) is the area under the first moment plasma concentration-time curve from time 0 to infinity.
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.
Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.
Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.
CLr is a measure of apparent clearance of the drug from the urine. The clearance is the rate at which waste substances are cleared from the blood.
CLr is a measure of apparent clearance of the drug from the urine.
| Arm | Type | Description |
|---|---|---|
| Fasted dosing followed by fed dosing | EXPERIMENTAL | Oral administration |
| Fed dosing followed by fasted dosing | EXPERIMENTAL | Oral administration |
| Name | Type | Description |
|---|---|---|
| SYR-322-MET | DRUG | Oral administration of SYR-322-MET |
Inclusion Criteria: 1. In the opinion of the investigator or subinvestigator, the subject is capable of understanding and complying with protocol requirements. 2. The subject signs and dates a written, informed consent form prior to the initiation of any study procedures. 3. The subject is a Japane...
SYR-322MET is an investigational fixed-dose combination of SYR-322 and metformin hydrochloride developed by Takeda Pharmaceutical Company Limited. It combines two active agents into a single oral tablet and has been studied in clinical pharmacology research in healthy adult male subjects in Japan.
SYR-322MET is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor behind the fixed-dose combination of SYR-322 and metformin hydrochloride studied in clinical pharmacology trials.
SYR-322MET has reached Phase 3 in its clinical development program. The Phase 3 study of the combination has been completed, and the asset remains investigational rather than an approved product.
SYR-322MET has been evaluated in one registered clinical trial, NCT02276274. That Phase 3 study examined the effect of food on the pharmacokinetics of a single oral dose of a fixed-dose combination of SYR-322 and metformin hydrochloride in healthy adult male subjects in Japan. It enrolled 12 participants and is completed.
Yes, SYR-322MET and SYR-322-MET refer to the same investigational fixed-dose combination developed by Takeda Pharmaceutical Company Limited. The two spellings are alternative names for the same asset, which pairs SYR-322 with metformin hydrochloride in a single oral dose.
NCT02276274 studied the effect of food on the pharmacokinetics of a single oral dose of a fixed-dose combination of SYR-322 and metformin hydrochloride. The Phase 3 trial was controlled, randomized, and enrolled 12 healthy adult male subjects aged 20 years and older in Japan. It is completed.