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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1167-0746 | Other Identifier | WHO | |
| JapicCTI-152813 | Registry Identifier | JapicCTI | |
| JapicCTI-R160849 | Registry Identifier | JapicCTI |
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The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25 milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.
Bioequivalence of 2 SYR-472 25 mg tablets and 1 SYR-472 50 mg tablet administered to healthy adult males will be investigated in a randomized, open-label, crossover study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants in group A will be orally administered 2 tablets of SYR-472 25 mg in period 1 and 1 tablet of SYR-472 50 mg tablet in period 2, both in a single dose under fasting conditions in the morning. |
|
| Group B | Experimental | Participants in group B will be orally administered 1 tablet of SYR-472 50 mg in period 1 and 2 tablets of SYR-472 25 mg tablets in period 2, both in a single dose under fasting conditions in the morning. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYR-472 | Drug | SYR-472 25mg, 50mg |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z) | Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period | |
| Cmax: Maximum Observed Plasma Concentration for SYR-472Z | Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for SYR-472Z | Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period | |
| Tmax: Time to Reach the Cmax for SYR-472Z |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan |
Healthy male participants were enrolled in 1 of the 2 treatment sequences in either Period 1 or 2: Group A: 25 milligram (mg) tablet in Period 1 followed by 50 mg tablet in Period 2, Group B: 50 mg tablet in Period 1 followed by 25 mg tablet in Period 2.
Participants took part in the study at 1 investigative site in Japan from 04 March 2015 to 08 April 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | SYR-472 25 mg + SYR-472 50 mg | SYR-472 25 mg, 2 tablets, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 50 mg, tablet, orally on Day 1 of the second intervention period (8 days). |
| FG001 | SYR-472 50 mg + SYR-472 25 mg | SYR-472 50 mg, 1 tablet, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 25 mg, 2 tablets, orally on Day 1 of the second intervention period (8 days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period (8 Days) |
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| Wash Out Period (13 Days) |
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| Second Intervention Period (8 Days) |
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The pharmacokinetic (PK) analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.
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| ID | Title | Description |
|---|---|---|
| BG000 | SYR-472 25 mg + SYR-472 50 mg | SYR-472 25 mg, 2 tablets, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 50 mg, tablet, orally on Day 1 of the second intervention period (8 days). |
| BG001 | SYR-472 50 mg + SYR-472 25 mg |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z) | The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK. | Posted | Geometric Mean | Standard Deviation | nanogram hour per milliliter(ng*hr/mL) | Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period |
|
Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SYR-472 25 mg | SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda (Note: This product was divested to Teijin Pharma Limited in 2023) | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| C000595449 | trelagliptin |
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| Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period |
| MRT: Mean Residence Time From Time Zero to Infinity for SYR-472Z | Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period |
| Apparent Terminal Elimination Rate Constant (λz) for SYR-472Z | Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period |
| Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) | Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Day 1). Routine collection of AEs continued until the end (hospital discharge) of Period 2 (Day 29). | Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2 |
| Number of Participants With TEAEs Related to Vital Signs | Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2 |
| Number of Participants With TEAEs Related to Body Weight | Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2 |
| Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values | Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2 |
| Number of Participants Who Had Abnormal and Clinically Significant 12-lead Electrocardiograms (ECG) Findings After Study Drug Administration | Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure. | Baseline up to 7 days after the last dose of study drug (Day 8) in each period |
| NOT COMPLETED |
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| NOT COMPLETED |
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SYR-472 50 mg, 1 tablet, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 25 mg, 2 tablets, orally on Day 1 of the second intervention period (8 days). |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | centimeter (cm) |
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| Weight | Mean | Standard Deviation | kilogram (kg) |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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| Smoking Classification | Number | participants |
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| Alcohol Classification | Number | participants |
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| Caffeine Classification | Number | participants |
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SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
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|
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| Primary | Cmax: Maximum Observed Plasma Concentration for SYR-472Z | The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK. | Posted | Geometric Mean | Standard Deviation | nanogram per milliliter(ng/mL) | Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period |
|
|
|
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| Secondary | AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for SYR-472Z | The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period |
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| Secondary | Tmax: Time to Reach the Cmax for SYR-472Z | The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK. | Posted | Median | Full Range | hour(hr) | Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period |
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| Secondary | MRT: Mean Residence Time From Time Zero to Infinity for SYR-472Z | The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK. | Posted | Geometric Mean | Standard Deviation | hr | Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period |
|
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|
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| Secondary | Apparent Terminal Elimination Rate Constant (λz) for SYR-472Z | The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK. | Posted | Geometric Mean | Standard Deviation | per hour(hr-1) | Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period |
|
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|
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| Secondary | Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) | Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Day 1). Routine collection of AEs continued until the end (hospital discharge) of Period 2 (Day 29). | The safety analysis set included all participants who received study drug. | Posted | Number | participants | Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2 |
|
|
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| Secondary | Number of Participants With TEAEs Related to Vital Signs | The safety analysis set included all participants who received study drug. | Posted | Number | participants | Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2 |
|
|
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| Secondary | Number of Participants With TEAEs Related to Body Weight | The safety analysis set included all participants who received study drug. | Posted | Number | participants | Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2 |
|
|
|
| Secondary | Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values | The safety analysis set included all participants who received study drug. | Posted | Number | participants | Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2 |
|
|
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| Secondary | Number of Participants Who Had Abnormal and Clinically Significant 12-lead Electrocardiograms (ECG) Findings After Study Drug Administration | Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure. | The safety analysis set included all participants who received study drug. | Posted | Number | participants | Baseline up to 7 days after the last dose of study drug (Day 8) in each period |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | SYR-472 50 mg | SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods. | 0 | 24 | 0 | 24 |
No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.