Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects

NCT ID: NCT02276274

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-06-30

Brief Summary

This is a randomized, open-label, crossover study to determine the effect of food when a combination tablet of SYR-322 and metformin hydrochloride ( hereinafter referred to as SYR-322-MET tablet) is orally administered under fasting conditions in the morning or after breakfast in Japanese healthy adult male subjects.

Detailed Description

The primary objective of this clinical trial is to determine the effect of food on the pharmacokinetics of single oral dose administration of SYR-322-MET tablets in Japanese healthy adult male subjects

Conditions

Clinical Pharmacology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fasted dosing followed by fed dosing

Oral administration

Group Type: EXPERIMENTAL

SYR-322-MET

Intervention Type: DRUG

Oral administration of SYR-322-MET

Fed dosing followed by fasted dosing

Oral administration

Group Type: EXPERIMENTAL

SYR-322-MET

Intervention Type: DRUG

Oral administration of SYR-322-MET

Interventions

SYR-322-MET

Oral administration of SYR-322-MET

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. In the opinion of the investigator or subinvestigator, the subject is capable of understanding and complying with protocol requirements.

2. The subject signs and dates a written, informed consent form prior to the initiation of any study procedures.

3. The subject is a Japanese healthy adult male.

4. The subject is aged 20 to 35 years, inclusive, at the time of informed consent.

5. The subject has a body weight of 50 kg or more with a BMI of ≥18.5 kg/m2 and <25.0 kg/m2 at screening.

Exclusion Criteria

1. The subject has received any investigational compound within 16 weeks (112 days) prior to the start of study drug administration in Period 1.

2. The subject has received SYR-322 or metformin hydrochloride in a previous clinical study or as a therapeutic agent.

3. The subject is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.

4. The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results.

5. The subject has a known hypersensitivity to drugs.

6. The subject has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at screening.

7. The subject has a history of drug abuse or history of alcohol abuse within 2 years prior to the screening visit or unwilling to agree to abstain from alcohol and drugs throughout the study.

8. Subject has taken any excluded medication, supplements, or food products during the time periods listed in the Excluded Medications and Dietary Products table.

9. Subject has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the subject's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking DPP-4 inhibitors or biguanides, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.

10. The subject has current or recent [within 24 weeks (168 days) prior to the initiation of study treatment in Period 1] gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [e.g., cholecystectomy]).

11. The subject has a history of cancer.

12. The subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at screening.

13. The subject has poor peripheral venous access.

14. The subject has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study medication administration Period 1.

15. The subject has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study medication administration in Period 1.

16. The subject has undergone blood component collection within 2 weeks (14 days) prior to the start of study medication administration in Period 1.

17. The subject has a screening or prior to the start of study medication administration on Day 1 in Period 1 hemoglobin level <12.5 g/dL.

18. The subject has a screening or prior to the start of study medication administration on Day 1 in Period 1 abnormal (clinically significant) 12-lead ECG.

19. Subject has abnormal screening or prior to the start of study medication administration on Day 1 in Period 1 laboratory values that suggest a clinically significant underlying disease or subject with the following lab abnormalities: ALT and/or AST >1.5 the upper limits of normal.

20. Subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

General Manager

Role: STUDY_DIRECTOR

Takeda Pharmaceutical Company Limited (Japan)

Locations

Fukuoka, Fukuoka, Japan

Countries

Japan

Other Identifiers

U1111-1157-8500

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-142584

Identifier Type: REGISTRY

Identifier Source: secondary_id

SYR-322-MET/CPH-002

Identifier Type: -

Identifier Source: org_study_id