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Trial record 46 of 854 for:    tablet | Japan

A Phase 1, Bioequivalence Study of SYR-472 25mg and 50mg Tablets

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ClinicalTrials.gov Identifier: NCT02372097
Recruitment Status : Completed
First Posted : February 26, 2015
Results First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Healthy
Intervention: Drug: SYR-472

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 1 investigative site in Japan from 04 March 2015 to 08 April 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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).
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).

Participant Flow for 3 periods

Period 1:   First Intervention Period (8 Days)
    SYR-472 25 mg + SYR-472 50 mg   SYR-472 50 mg + SYR-472 25 mg
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 

Period 2:   Wash Out Period (13 Days)
    SYR-472 25 mg + SYR-472 50 mg   SYR-472 50 mg + SYR-472 25 mg
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 

Period 3:   Second Intervention Period (8 Days)
    SYR-472 25 mg + SYR-472 50 mg   SYR-472 50 mg + SYR-472 25 mg
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).
Total Total of all reporting groups

Baseline Measures
   SYR-472 25 mg + SYR-472 50 mg   SYR-472 50 mg + SYR-472 25 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 23.7  (2.64)   22.3  (3.17)   23.0  (2.93) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   12   12   24 
Region of Enrollment 
[Units: Participants]
     
Japan   12   12   24 
Height 
[Units: Centimeter (cm)]
Mean (Standard Deviation)
 172.0  (6.93)   172.8  (7.48)   172.4  (7.06) 
Weight 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
 64.51  (9.707)   62.79  (6.087)   63.65  (7.972) 
Body Mass Index (BMI) 
[Units: Kilogram per square meter (kg/m^2)]
Mean (Standard Deviation)
 21.69  (1.866)   21.05  (1.948)   21.37  (1.894) 
Smoking Classification 
[Units: Participants]
     
Never Smoked   7   7   14 
Current Smoker   5   4   9 
Ex-Smoker   0   1   1 
Alcohol Classification 
[Units: Participants]
     
Drinks a Few Days per Week   2   5   7 
Drinks a Few Days per Month   7   4   11 
Never Drunk   3   3   6 
Caffeine Classification 
[Units: Participants]
     
Caffeine Consumer   4   2   6 
Caffeine Non-Consumer   8   10   18 


  Outcome Measures

1.  Primary:   AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z)   [ Time Frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period ]

2.  Primary:   Cmax: Maximum Observed Plasma Concentration for SYR-472Z   [ Time Frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period ]

3.  Secondary:   AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for SYR-472Z   [ Time Frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period ]

4.  Secondary:   Tmax: Time to Reach the Cmax for SYR-472Z   [ Time Frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period ]

5.  Secondary:   MRT: Mean Residence Time From Time Zero to Infinity for SYR-472Z   [ Time Frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period ]

6.  Secondary:   Apparent Terminal Elimination Rate Constant (λz) for SYR-472Z   [ Time Frame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period ]

7.  Secondary:   Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs)   [ Time Frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2 ]

8.  Secondary:   Number of Participants With TEAEs Related to Vital Signs   [ Time Frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2 ]

9.  Secondary:   Number of Participants With TEAEs Related to Body Weight   [ Time Frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2 ]

10.  Secondary:   Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values   [ Time Frame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2 ]

11.  Secondary:   Number of Participants Who Had Abnormal and Clinically Significant 12-lead Electrocardiograms (ECG) Findings After Study Drug Administration   [ Time Frame: Baseline up to 7 days after the last dose of study drug (Day 8) in each period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02372097     History of Changes
Other Study ID Numbers: SYR-472-1005
U1111-1167-0746 ( Other Identifier: WHO )
JapicCTI-152813 ( Registry Identifier: JapicCTI )
JapicCTI-R160849 ( Registry Identifier: JapicCTI )
First Submitted: February 20, 2015
First Posted: February 26, 2015
Results First Submitted: April 8, 2016
Results First Posted: May 13, 2016
Last Update Posted: May 13, 2016