Phase 1 Bioavailability Study of SYR-322MET

NCT02508168 | Completed Phase 1

• 2 other identifiers: SYR-322MET-1003U1111-1168-6473
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the relative bioavailability of alogliptin 12.5 milligram (mg) and immediate-release metformin 1000 mg when administered as individual tablets and as a fixed-dose combination (FDC) product.

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (4)

• AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alogliptin

  (AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).

  Day 1 predose and at multiple time points (up to 72 hours) post-dose.

• Cmax: Maximum Observed Plasma Concentration for Alogliptin

  Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

  Day 1 predose and at multiple time points (up to 72 hours) post-dose.

• AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Metformin

  (AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).

  Day 1 predose and at multiple time points (up to 72 hours) post-dose.

• Cmax: Maximum Observed Plasma Concentration for Metformin

  Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

  Day 1 predose and at multiple time points (up to 72 hours) post-dose.

Secondary Outcomes (4)

• Percentage of Participants who Experience at Least one Post-dose Adverse Event (AE)

  Day 1 of Period 1 up to 30 days after the last dose of study medication (up to 38 days)

• Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose

  At Day 4 and Day 7 of Period 2

• Percentage Of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose

  Day 1 up to Day 4 of each period

• Percentage of Participants who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose

  At Day 1 and Day 4 of each period

Study Arms (2)

Sequence I: AB

EXPERIMENTAL

SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg) fixed-dose combination (FDC) tablets, orally, once, on Day 1 of Period 1, followed by a 7-day washout period, followed by alogliptin 12.5 mg tablets and metformin 1000 mg tablets, orally, once, on Day 1 of Period 2.

Drug: Alogliptin; Drug: Metformin Hydrochloride; Drug: SYR-322MET

Sequence II: BA

EXPERIMENTAL

Alogliptin 12.5 mg tablets, orally and metformin 1000 mg tablets, orally, once, on Day 1 of Period 1, followed by a 7-day washout period, followed by SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg) fixed-dose combination (FDC) tablets, orally, once, on Day 1 of Period 2.

Drug: Alogliptin; Drug: Metformin Hydrochloride; Drug: SYR-322MET

Interventions

Alogliptin DRUG

Alogliptin 12.5 mg tablets

Also known as: Vipidia

Sequence I: AB; Sequence II: BA

Metformin Hydrochloride DRUG

Metformin hydrochloride 1000 mg tablets

Also known as: Glucophage

Sequence I: AB; Sequence II: BA

SYR-322MET DRUG

SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg) fixed-dose combination (FDC) tablets

Sequence I: AB; Sequence II: BA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
• Is a healthy male or female.
• Is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
• Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 30.0 kilogram per square meter (kg/m\^2), inclusive at Screening.
• A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.
• A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study and for 30 days after last dose.

You may not qualify if:

• Has received any investigational compound within 30 days prior to Check-in (Day-1).
• Has received alogliptin or metformin hydrochloride (HCl) in a previous clinical study or as a therapeutic agent within 90 days prior to Check-in (Day-1).
• Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
• Has clinically significant history or current diagnosis of cardiovascular, respiratory, neurological, endocrine, hematopoietic, immune, urinary, genital, gastrointestinal, hepatic and psychiatric diseases.
• Has fasting blood glucose lower than 3.88 millimoles per liter (mmol/L)
• Has experienced acute infectious diseases within 4 weeks before screening.
• Has a history of clinically significant allergic reactions or has a known hypersensitivity to any component of the formulation of alogliptin, metformin or related compounds.
• Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) or positive alcohol breath test at Screening or Check-in (Day -1).
• Consumes over 10 drinks weekly (1 drink is equivalent to 0.5 liters of beer, 200 milliliter \[mL\] of dry wine or 50 mL of hard liquor) or has a history of alcoholism, drug and/or substance abuse.
• Has taken any excluded medication, supplements, or food products during the time periods listed in the Excluded Medications and Dietary Products table, including intake of medicines with pronounced effects on blood circulation, liver function (barbiturates, omeprazole, cimetidine, etc.) within 2 months before Day -1 of Period 1.
• If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
• If male, the participant intends to donate sperm during the course of this study or for 12 weeks after the last dose of study medication.
• If female, the subject is having unprotected sex with non-sterilized men within 30 days before the IMP administration.
• Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent \[more than once per week\] occurrence of heartburn, or any surgical intervention.
• Has non-standard diet (example, vegetarian or vegan) or lifestyle (including nighttime work, extreme physical activity such as weights lifting), which may interfere with the trial.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Interventions

alogliptin; Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

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: July 23, 2015
• First Posted: July 24, 2015
• Study Start: April 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 5, 2016

Record last verified: 2016-10