Clinical trial NCT02372097: A Phase 1, Bioequivalence Study of SYR-472 25mg and 50mg Tablets
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-02-26
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z)
timeFrame: 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: Cmax: Maximum Observed Plasma Concentration for SYR-472Z
timeFrame: Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period
Secondary outcomes:
measure: AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for SYR-472Z
timeFrame: 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: Tmax: Time to Reach the Cmax for SYR-472Z
timeFrame: 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: MRT: Mean Residence Time From Time Zero to Infinity for SYR-472Z
timeFrame: 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: Apparent Terminal Elimination Rate Constant (λz) for SYR-472Z
timeFrame: 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: Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
measure: Number of Participants With TEAEs Related to Vital Signs
timeFrame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
measure: Number of Participants With TEAEs Related to Body Weight
timeFrame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
measure: Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
timeFrame: Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2
measure: Number of Participants Who Had Abnormal and Clinically Significant 12-lead Electrocardiograms (ECG) Findings After Study Drug Administration
timeFrame: Baseline up to 7 days after the last dose of study drug (Day 8) in each period
Other outcomes:
Locations:
city: Fukuoka
country: Japan
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: