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Trial record 53 of 960 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

Tracking Information
First Submitted Date  ICMJE February 20, 2015
First Posted Date  ICMJE February 26, 2015
Results First Submitted Date  ICMJE April 8, 2016
Results First Posted Date  ICMJE May 13, 2016
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for unchanged SYR-472 (AUC(0-168)) [ Time Frame: 21 days ]
    AUC(0-168) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau)), where tau is the length of the dosing interval - 168 hours in this study)
  • Maximum Observed Plasma Concentration at Steady State for unchanged SYR-472 (Cmax) [ Time Frame: 21 days ]
    Maximum observed steady-state plasma concentration during a dosing interval.
Change History Complete list of historical versions of study NCT02372097 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
    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).
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
    Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for unchanged SYR-472 (AUC(0-inf)) [ Time Frame: 21 days ]
    AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau)), where tau is the length of the dosing interval in this study).
  • Time to Reach the Maximum Plasma Concentration (Cmax) for unchanged SYR-472 (Tmax) [ Time Frame: 21 days ]
    Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
  • Mean Residence Time for unchanged SYR-472 (MRT) [ Time Frame: 21 days ]
    Mean Residence Time is the mean of the time that a drug spend in the body.
  • Terminal Elimination Rate Constant (λz) for unchanged SYR-472 [ Time Frame: 21 days ]
    Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.
  • Frequency of treatment emergent adverse events (TEAEs) [ Time Frame: 21 days ]
    The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness, and causal relationship to SYR-472. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, reported from the first dose to the last dose of SYR-472. TEAEs are defined as events occurring after the start of administration of an investigational product or events that occur due to the worsening of the present illness.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1, Bioequivalence Study of SYR-472 25mg and 50mg Tablets
Official Title  ICMJE A Randomized, Open-label, Crossover Phase 1 Study to Evaluate the Bioequivalence Following a Single Oral Dose Administration of SYR-472 25mg and 50mg Tablets in Healthy Adult Male Subjects
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: SYR-472
SYR-472 25mg, 50mg
Study Arms  ICMJE
  • Experimental: Group A
    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.
    Intervention: Drug: SYR-472
  • Experimental: Group B
    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.
    Intervention: Drug: SYR-472
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2015)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participants who understand the outline of the clinical study and are capable of complying with their responsibilities as participants, as judged by the investigator or sub investigator.
  2. Participants who can sign and date the informed consent form before the initiation of the study procedure.
  3. Healthy Japanese adult males.
  4. Participants who are 20 to 35 years of age at the time of informed consent.
  5. Participants who weigh 50.0 kilogram (kg) or more with a body mass index (BMI) of 18.5 to less than 25.0 kilogram per square meter (kg/m^2) in the screening period.

Exclusion Criteria:

  1. Participants who were administered any investigational product within 16 weeks (112 days) before the start of the study drug administration in stage 1.
  2. Participants who have received SYR-472 in the past.
  3. Employees of the study site, their family members, those who are in a dependency relationship with employees of the study site involved in the conduct of the study (for example [e.g.], spouse, parents, children, brothers and sisters), and those who might be coerced to consent to participate in the study.
  4. Participants who have poorly controlled, clinically significant abnormalities of the nervous system, cardiovascular system, lung, liver, kidneys, metabolism, gastrointestinal system, urinary system, or endocrinological system, which possibly may affect study participation or study results.
  5. Participants who have a positive urine drug test in the screening period.
  6. Participants who need to use drugs or foods listed in the table of prohibited concomitant drugs and foods.
  7. Participants who have a history of hypersensitivity or allergy to drugs (including SYR-472 and its ingredients).
  8. Participants who currently have or recently had (within the past 6 months) gastrointestinal disease that may affect drug absorption (malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [at least once a week] heartburn, surgical intervention [e.g., cholecystectomy]).
  9. Participants with a past history of cancer.
  10. Participants who are positive for any of the following during the screening period: hepatitis B virus surface antigen (HBsAg), antibody against hepatitis C virus (HCV), human immunodeficiency virus (HIV) antigen, anti-HIV antibody, or serological test for syphilis.
  11. Participants with difficulty having blood collected from a peripheral vein.
  12. Participants who donated 200 milliliter (mL) or more of whole blood within the 4 weeks (28 days) or 400 mL or more of whole blood within the 12 weeks (84 days) before starting the study drug administration in stage 1.
  13. Participants who donated a total of 800 mL or more of whole blood within the 52 weeks (364 days) before starting the study drug administration in stage 1.
  14. Participants who donated blood components within the 2 weeks (14 days) before starting the study drug administration in stage 1.
  15. Participants who show clinically significant abnormalities in electrocardiogram (ECG) during the screening period or on Day 1 (before the study drug administration).
  16. Participants who have laboratory test abnormalities suggestive of a clinically significant primary disease or who have abnormal values in any of the following parameters: alanine aminotransferase (ALT) or aspartate serum transaminase AST exceeding 1.5 times the upper limit of the normal range.
  17. Participants who are unlikely to comply with the study protocol or are ineligible for the study for any other reason, as judged by the investigator or sub investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02372097
Other Study ID Numbers  ICMJE SYR-472-1005
U1111-1167-0746 ( Other Identifier: WHO )
JapicCTI-152813 ( Registry Identifier: JapicCTI )
JapicCTI-R160849 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Takeda
PRS Account Takeda
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP