Clinical PharmacologyPhase 3NCT02276274

Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects

A Phase 3 study testing SYR-322-MET in people with Clinical Pharmacology, run by Takeda at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a randomized, open-label, crossover study to determine the effect of food when a combination tablet of SYR-322 and metformin hydrochloride ( hereinafter referred to as SYR-322-MET tablet) is orally administered under fasting conditions in the morning or after breakfast in Japanese healthy adult male subjects. Read more about this study

Who is it for?: Ages 20 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Clinical Pharmacology
What is being tested?: SYR-322-MET
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteJapan
Study dates: Jun 2014to Jun 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

In the opinion of the investigator or subinvestigator, the subject is capable of understanding and complying with protocol requirements.
The subject signs and dates a written, informed consent form prior to the initiation of any study procedures.
The subject is a Japanese healthy adult male.
The subject is aged 20 to 35 years, inclusive, at the time of informed consent.
The subject has a body weight of 50 kg or more with a BMI of ≥18.5 kg/m2 and <25.0 kg/m2 at screening.

Who cannot join

The subject has received any investigational compound within 16 weeks (112 days) prior to the start of study drug administration in Period 1.
The subject has received SYR-322 or metformin hydrochloride in a previous clinical study or as a therapeutic agent.
The subject is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results.
The subject has a known hypersensitivity to drugs.
The subject has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at screening.

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The subject has a history of drug abuse or history of alcohol abuse within 2 years prior to the screening visit or unwilling to agree to abstain from alcohol and drugs throughout the study.
Subject has taken any excluded medication, supplements, or food products during the time periods listed in the Excluded Medications and Dietary Products table.
Subject has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the subject's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking DPP-4 inhibitors or biguanides, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
The subject has current or recent [within 24 weeks (168 days) prior to the initiation of study treatment in Period 1] gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [e.g., cholecystectomy]).
The subject has a history of cancer.
The subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at screening.
The subject has poor peripheral venous access.
The subject has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study medication administration Period 1.
The subject has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study medication administration in Period 1.
The subject has undergone blood component collection within 2 weeks (14 days) prior to the start of study medication administration in Period 1.
The subject has a screening or prior to the start of study medication administration on Day 1 in Period 1 hemoglobin level <12.5 g/dL.
The subject has a screening or prior to the start of study medication administration on Day 1 in Period 1 abnormal (clinically significant) 12-lead ECG.
Subject has abnormal screening or prior to the start of study medication administration on Day 1 in Period 1 laboratory values that suggest a clinically significant underlying disease or subject with the following lab abnormalities: ALT and/or AST >1.5 the upper limits of normal.
Subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Fukuoka, Fukuoka

Other trials in Japan

About this study

Official title: A Randomized, Open-label, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects

Read the detailed description

The primary objective of this clinical trial is to determine the effect of food on the pharmacokinetics of single oral dose administration of SYR-322-MET tablets in Japanese healthy adult male subjects

Conditions: Clinical Pharmacology
Being tested: SYR-322-MET

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SYR-322-METDrug
Oral administration of SYR-322-MET

Study groups in NCT02276274
Study group	Role	What they receive
Fasted dosing followed by fed dosing	Experimental	Oral administration Receives: Drug: SYR-322-MET
Fed dosing followed by fasted dosing	Experimental	Oral administration Receives: Drug: SYR-322-MET

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Unchanged SYR-322 (SYR-322Z)
AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322Z
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]).
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Cmax: Maximum Observed Plasma Concentration for SYR-322Z
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322Z
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322Z
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Apparent Terminal Elimination Rate Constant (λz) for SYR-322Z
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.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Terminal Phase Elimination Half-life (T1/2) for SYR-322Z
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Apparent Clearance After Extra Vascular Administration (CL/F) for SYR-322Z
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).
Measured: 3 hours prior to administration, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours after administration
Mean Residence Time (MRT) for SYR-322Z
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.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322Z
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.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post Dose for SYR-322 Metabolites M-I and M-II
AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322 Metabolites M-I and M-II
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]).
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322 Metabolites M-I and M-II
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.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Cmax: Maximum Observed Plasma Concentration for SYR-322 Metabolites M-I and M-II
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322 Metabolites M-I and M-II
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322 Metabolites M-I and M-II
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Apparent Terminal Elimination Rate Constant (λz) for SYR-322 Metabolites M-I and M-II
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.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Terminal Phase Elimination Half-life (T1/2) for SYR-322 Metabolites M-I and M-II
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Mean Residence Time (MRT) for SYR-322 Metabolites M-I and M-II
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.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUC (0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for Metformin
AUC (0-48) is measure of area under the curve from time 0 to 48 hours post dose.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
AUC (0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Metformin
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]).
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for Metformin
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.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Cmax: Maximum Observed Plasma Concentration for Metformin
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Metformin
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Metformin
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Apparent Terminal Elimination Rate Constant (λz) for Metformin
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.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Terminal Phase Elimination Half-life (T1/2) for Metformin
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Apparent Clearance After Extra Vascular Administration (CL/F) for Metformin
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in L/hr.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Mean Residence Time (MRT) for Metformin
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.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Urinary Excretion Ratio of SYR-322Z From 0 to 12 Hours Postdose
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Measured: 0 to 12 hours postdose
Urinary Excretion Ratio of SYR-322Z From 0 to 24 Hours Postdose
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Measured: 0 to 24 hours postdose
Urinary Excretion Ratio of SYR-322Z From 0 to 48 Hours Postdose
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Measured: 0 to 48 hours postdose
Urinary Excretion Ratio of SYR-322Z From 0 to 72 Hours Postdose
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Measured: 0 to 72 hours postdose
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 12 Hours Postdose
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Measured: 0 to 12 hours postdose
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 24 Hours Postdose
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Measured: 0 to 24 hours post dose
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 48 Hours Postdose
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Measured: 0 to 48 hours postdose
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 72 Hours Postdose
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Measured: 0 to 72 hours postdose
Urinary Excretion Ratio of Metformin From Time 0 to 12 Hours Postdose
Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.
Measured: 0 to 12 hours postdose
Urinary Excretion Ratio of Metformin From 0 to 24 Hours Postdose
Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.
Measured: 0 to 24 hours postdose
Urinary Excretion Ratio of Metformin From 0 to 48 Hours Postdose
Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.
Measured: 0 to 48 hours postdose
CLr: Renal Clearance of SYR-322Z
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.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
CLr: Renal Clearance of Metformin
CLr is a measure of apparent clearance of the drug from the urine.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose

Secondary outcomes (10)

Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
DPP-4 activity and inhibition rate of DPP-4 activity was assessed from the plasma samples collected from the participants. Inhibition of DPP-4 enzyme was used to determine the antihyperglycemic activity of the investigational product.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose
DPP-4 Activity
DPP-4 activity was assessed from the plasma samples collected from the participants.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose
AUC (0-24): Area Under the Inhibition Rate of Plasma DPP-4 Activity-time Curve From Time 0 to 24 Hours
Area under the inhibition rate of plasma DPP-4 activity-time curve from time 0 to 24 hours was determined from the inhibition-time curve.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose
Emax: Maximum Inhibition Rate of Plasma DPP-4 Activity
Maximum inhibition rate of plasma DPP-4 activity was determined from the inhibition-time curve.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose
Tmax: Time to Reach Emax
Time to reach Emax for the first time was determined from the inhibition-time curve.
Measured: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose
Number of Participants Reporting 1 or More Treatment-emergent Adverse Events
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Baseline up to the day of discharge (Day 4) in the second intervention period
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs included body temperature (infra-axillary), supine blood pressure resting more than 5 minutes (systolic and diastolic [Millimeters of mercury]), respiratory rate and pulse (beats per minute). Clinically significant change in vital signs observed at any time point are reported.
Measured: 3 hours prior to administration (predose) and 2, 24 and 72 hours postdose
Number of Participants With Clinically Significant Change From Baseline in Body Weight
Clinically significant change participant's body weight observed at any time point are reported.
Measured: 3 hours prior to administration (predose), 24 and 72 hours postdose
Number of Participants With Significant Change From Baseline in Electrocardiograms
Clinically significant change in electrocardiograms observed at any time point are reported.
Measured: 3 hours prior to administration (predose) and 2, 24 and 72 hours postdose
Number of Participants With Laboratory-related Treatment Emergent Adverse Events (TEAEs)
Laboratory assessments included hematology, serum chemistry and urinalysis. Any laboratory-related TEAE reported at any time point were reported in this measure.
Measured: 3 hours prior to administration (predose), 24 and 72 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Jun 2014

First posted28 Oct 2014 (estimated)
Study startJun 2014
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Clinical PharmacologyStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02276274
Sponsor's protocol ID: SYR-322-MET/CPH-002
Other IDs: U1111-1157-8500, JapicCTI-142584
Status last verified: Aug 2023
First submitted: 26 Jun 2014
Last updated: 21 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT02276274
Acronym / sponsor ID: SYR-322-MET/CPH-002
Conditions: Clinical Pharmacology
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 28 Oct 2014 (estimated)
Results: Posted 29 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fasted dosing followed by fed dosing	Experimental	Drug: SYR-322-METOral administration
Fed dosing followed by fasted dosing	Experimental	Drug: SYR-322-METOral administration

Who may qualify

Ages: 20 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

In the opinion of the investigator or subinvestigator, the subject is capable of understanding and complying with protocol requirements.
The subject signs and dates a written, informed consent form prior to the initiation of any study procedures.
The subject is a Japanese healthy adult male.
The subject is aged 20 to 35 years, inclusive, at the time of informed consent.
The subject has a body weight of 50 kg or more with a BMI of ≥18.5 kg/m2 and <25.0 kg/m2 at screening.

Key exclusion criteria (20 listed)

The subject has received any investigational compound within 16 weeks (112 days) prior to the start of study drug administration in Period 1.
The subject has received SYR-322 or metformin hydrochloride in a previous clinical study or as a therapeutic agent.
The subject is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results.
The subject has a known hypersensitivity to drugs.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SYR-322-METOral administration of SYR-322-MET	Drug	Fasted dosing followed by fed dosing, Fed dosing followed by fasted dosing

Primary outcome

AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Unchanged SYR-322 (SYR-322Z)
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.
AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322Z
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
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]).
Cmax: Maximum Observed Plasma Concentration for SYR-322Z
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
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) for SYR-322Z
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322Z
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Apparent Terminal Elimination Rate Constant (λz) for SYR-322Z
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
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) for SYR-322Z
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Apparent Clearance After Extra Vascular Administration (CL/F) for SYR-322Z
Time frame: 3 hours prior to administration, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours after administration
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) for SYR-322Z
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
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): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322Z
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
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): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post Dose for SYR-322 Metabolites M-I and M-II
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.
AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322 Metabolites M-I and M-II
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
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): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322 Metabolites M-I and M-II
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
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.
Cmax: Maximum Observed Plasma Concentration for SYR-322 Metabolites M-I and M-II
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
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) for SYR-322 Metabolites M-I and M-II
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322 Metabolites M-I and M-II
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Apparent Terminal Elimination Rate Constant (λz) for SYR-322 Metabolites M-I and M-II
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
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) for SYR-322 Metabolites M-I and M-II
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
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) for SYR-322 Metabolites M-I and M-II
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
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): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for Metformin
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
AUC (0-48) is measure of area under the curve from time 0 to 48 hours post dose.
AUC (0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Metformin
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
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): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for Metformin
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
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.
Cmax: Maximum Observed Plasma Concentration for Metformin
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
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) for Metformin
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Metformin
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Apparent Terminal Elimination Rate Constant (λz) for Metformin
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
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) for Metformin
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Apparent Clearance After Extra Vascular Administration (CL/F) for Metformin
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
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) for Metformin
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
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.
Urinary Excretion Ratio of SYR-322Z From 0 to 12 Hours Postdose
Time frame: 0 to 12 hours postdose
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Urinary Excretion Ratio of SYR-322Z From 0 to 24 Hours Postdose
Time frame: 0 to 24 hours postdose
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Urinary Excretion Ratio of SYR-322Z From 0 to 48 Hours Postdose
Time frame: 0 to 48 hours postdose
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Urinary Excretion Ratio of SYR-322Z From 0 to 72 Hours Postdose
Time frame: 0 to 72 hours postdose
Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 12 Hours Postdose
Time frame: 0 to 12 hours postdose
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 24 Hours Postdose
Time frame: 0 to 24 hours post dose
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 48 Hours Postdose
Time frame: 0 to 48 hours postdose
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 72 Hours Postdose
Time frame: 0 to 72 hours postdose
Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.
Urinary Excretion Ratio of Metformin From Time 0 to 12 Hours Postdose
Time frame: 0 to 12 hours postdose
Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.
Urinary Excretion Ratio of Metformin From 0 to 24 Hours Postdose
Time frame: 0 to 24 hours postdose
Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.
Urinary Excretion Ratio of Metformin From 0 to 48 Hours Postdose
Time frame: 0 to 48 hours postdose
Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.
CLr: Renal Clearance of SYR-322Z
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose
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: Renal Clearance of Metformin
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
CLr is a measure of apparent clearance of the drug from the urine.

10 secondary outcomes

Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose
DPP-4 Activity
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose
AUC (0-24): Area Under the Inhibition Rate of Plasma DPP-4 Activity-time Curve From Time 0 to 24 Hours
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose
Emax: Maximum Inhibition Rate of Plasma DPP-4 Activity
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose
Tmax: Time to Reach Emax
Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose
Number of Participants Reporting 1 or More Treatment-emergent Adverse Events
Time frame: Baseline up to the day of discharge (Day 4) in the second intervention period
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: 3 hours prior to administration (predose) and 2, 24 and 72 hours postdose
Number of Participants With Clinically Significant Change From Baseline in Body Weight
Time frame: 3 hours prior to administration (predose), 24 and 72 hours postdose
Number of Participants With Significant Change From Baseline in Electrocardiograms
Time frame: 3 hours prior to administration (predose) and 2, 24 and 72 hours postdose
Number of Participants With Laboratory-related Treatment Emergent Adverse Events (TEAEs)
Time frame: 3 hours prior to administration (predose), 24 and 72 hours postdose

Results and safety

Results posted to the registry on 29 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SYR-322-MET Fasted Followed by SYR-322-MET Fed	6	6
SYR-322-MET Fed Followed by SYR-322-MET Fasted	6	6

Primary outcome: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Unchanged SYR-322 (SYR-322Z)

Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose. Mean (Standard Deviation). Unit: nanogram*milliliter per hour (ng*hr/mL)

Measure	SYR-322-MET Fasted n = 12	SYR-322-MET Fed n = 12
Value	1494.9 (159.42)	1472.8 (172.59)

SYR-322-MET Fasted vs SYR-322-MET Fed: Least Squares Mean Difference: -0.0164 (90% CI -0.0592 to 0.0264)

Population analysed: Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.

Primary outcome: AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322Z

Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	SYR-322-MET Fasted n = 12	SYR-322-MET Fed n = 12
Value	1494.9 (159.42)	1472.8 (172.59)

SYR-322-MET Fasted vs SYR-322-MET Fed: Least Squares Mean Difference: -0.0164 (90% CI -0.0592 to 0.0264)

Primary outcome: Cmax: Maximum Observed Plasma Concentration for SYR-322Z

Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose. Mean (Standard Deviation). Unit: ng/mL

Measure	SYR-322-MET Fasted n = 12	SYR-322-MET Fed n = 12
Value	154.9 (38.72)	173.4 (38.45)

SYR-322-MET Fasted vs SYR-322-MET Fed: Least Squares Mean Difference: 0.1182 (90% CI -0.0405 to 0.2769)

Primary outcome: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322Z

Time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose. Median (Full Range). Unit: hour (hr)

Measure	SYR-322-MET Fasted n = 12	SYR-322-MET Fed n = 12
Value	3.000 (2.00 to 4.00)	1.00 (0.50 to 3.00)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of the study drug and up to the day of discharge (Day 4) in the second intervention period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SYR-322-MET Fasted	0 of 12 (0%)	0 of 12 (0%)	Not reported
SYR-322-MET Fed	0 of 12 (0%)	0 of 12 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

General Manager study director

Takeda Pharmaceutical Company Limited (Japan)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SYR-322-MET in people with Clinical Pharmacology, run by Takeda at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Unchanged SYR-322 (SYR-322Z) (time frame: 3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02276274.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.