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

NCT02372097 | Completed Phase 1 Results

• 4 other identifiers: SYR-472-1005U1111-1167-0746JapicCTI-152813JapicCTI-R160849
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• 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

  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)

  Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2

Study Arms (2)

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.

Drug: SYR-472

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.

Drug: SYR-472

Interventions

SYR-472 DRUG

SYR-472 25mg, 50mg

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Participants who can sign and date the informed consent form before the initiation of the study procedure.
• Healthy Japanese adult males.
• Participants who are 20 to 35 years of age at the time of informed consent.
• 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.

You may not qualify if:

• Participants who were administered any investigational product within 16 weeks (112 days) before the start of the study drug administration in stage 1.
• Participants who have received SYR-472 in the past.
• 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.
• 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.
• Participants who have a positive urine drug test in the screening period.
• Participants who need to use drugs or foods listed in the table of prohibited concomitant drugs and foods.
• Participants who have a history of hypersensitivity or allergy to drugs (including SYR-472 and its ingredients).
• 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 \[e.g., cholecystectomy\]).
• Participants with a past history of cancer.
• 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.
• Participants with difficulty having blood collected from a peripheral vein.
• 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.
• 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.
• Participants who donated blood components within the 2 weeks (14 days) before starting the study drug administration in stage 1.
• Participants who show clinically significant abnormalities in electrocardiogram (ECG) during the screening period or on Day 1 (before the study drug administration).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Fukuoka, Japan

Location

MeSH Terms

Interventions

trelagliptin

Results Point of Contact

• Title: Medical Director
• Organization: Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: February 26, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 22, 2023
• Results First Posted: May 13, 2016

Record last verified: 2023-12

Locations

JP (1)