A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Metformin

Study Overview
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Brief Summary
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The objective of this study is to evaluate the pharmacokinetic interactions between ASP015K and metformin in healthy non-elderly male subjects.

Official Title
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ASP015K Pharmacokinetic Study: Evaluation of Drug-Drug Interaction Between ASP015K and Metformin

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: peficitinib
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight at screening: ≥ 50.0 kg, < 80.0 kg BMI at screening: ≥ 17.6, < 26.4 Subjects who agree to use highly effective contraception as consisting of two forms of birth control (at least one of which must be a barrier method) from getting informed consent through 90 days after the final study drug administration. Subjects who agree NOT to donate sperm from getting informed consent through 90 days after the final study drug administration. Exclusion Criteria: Subjects who received or are scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -1). Subjects who received or is scheduled to receive any medications (including over-the-counter drugs) within seven days before the hospital admission (Day -1). Subjects who received ASP015K or metformin previously. Subjects who have a habit of excessive alcohol drinking or smoking. Any deviation from the normal range of blood pressure, pulse, body temperature, or 12-lead ECG at screening or on the day of hospital admission (Day -1). Subjects who meet any of the following criterion for laboratory tests at screening or on the day of hospital admission (Day -1). Normal ranges of each test specified at the study site or test/assay organization will be used as the normal ranges in this study. Subjects with a complication or history of drug allergies. Subjects who have a history of clinically serious allergy, which induces generalized urticaria or anaphylactic shock requiring hospital admission. Subjects with a complication or history of hepatic disease, renal disease, cardiac disease, congenital short QT syndrome, respiratory disease , gastrointestinal disease. Subjects with a history of gastrointestinal resection. Subjects who developed upper gastrointestinal symptoms within seven days before the hospital admission (Day -1). Subjects with a complication or history of endocrine disease, cerebrovascular disease, malignant tumor, lymphatic disease , lactic acidosis. Subjects who apply to any of the concerns with regard to tuberculosis. Subjects who apply to any of the concerns with regard to infection other than tuberculosis. Subjects with vaccination of live vaccines or live attenuated vaccines within 56 days before the hospital admission (Day -1).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP015K and Metformin<br>Subjects will receive a single oral dose of metformin on Days 1 and 10, a single dose of ASP015K on Day 3 and multiple doses of ASP015K once daily Day 5 to Day 11. Subjects will receive a single dose of metformin and ASP015K concurrently on Day 10. | Drug: peficitinib<br>* Oral<br>* Other names: ASP015K;Drug: Metformin<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) parameter of metformin in plasma: AUCinf | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity | Up to Day 12 | 
| PK parameter of metformin in plasma: Cmax | Cmax: Maximum concentration | Up to Day 12 | 
| PK parameter of metformin in plasma: AUClast | AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration | Up to Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameter of metformin in plasma: CL/F | CL/F: Apparent total systemic clearance | Up to Day 12 | 
| PK parameter of metformin in plasma: t1/2 | t1/2: Terminal elimination half-life | Up to Day 12 | 
| PK parameter of metformin in plasma: tmax | tmax: Time of Cmax | Up to Day 12 | 
| PK parameter of metformin in plasma: Vz/F | Vz/F: Apparent volume of distribution during the terminal elimination phase | Up to Day 12 | 
| PK parameter of metformin in urine: Aelast | Aelast: Amount of metformin excreted into the urine from the time of dosing to the last measurable concentration | Up to Day 12 | 
| PK parameter of metformin in urine: Aelast% | Aelast%: Percent of metformin excreted into the urine from the time of dosing to the last measurable concentration | Up to Day 12 | 
| PK parameter of metformin in urine: CLR | CLR: Renal clearance | Up to Day 12 | 
| PK parameter of ASP015K in plasma: AUCinf |  | Up to Day 12 | 
| PK parameter of ASP015K in plasma: AUClast |  | Up to Day 12 | 
| PK parameter of ASP015K in plasma: AUCtau | AUCtau: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval | Up to Day 12 | 
| PK parameter of ASP015K in plasma: CL/F |  | Up to Day 12 | 
| PK parameter of ASP015K in plasma: Cmax |  | Up to Day 12 | 
| PK parameter of ASP015K in plasma: Ctrough | Ctrough: Concentration immediately prior to dosing at multiple dosing | Up to Day 12 | 
| PK parameter of ASP015K in plasma: PTR | PTR: Peak trough ratio | Up to Day 12 | 
| PK parameter of ASP015K in plasma: Rac | Rac: accumulation ratio | Up to Day 12 | 
| PK parameter of ASP015K in plasma: t1/2 |  | Up to Day 12 | 
| PK parameter of ASP015K in plasma: tmax |  | Up to Day 12 | 
| PK parameter of ASP015K in plasma: Vz/F |  | Up to Day 12 | 
| PK parameter of metabolites of ASP015K in plasma: AUCinf |  | Up to Day 12 | 
| PK parameter of metabolites of ASP015K in plasma: AUClast |  | Up to Day 12 | 
| PK parameter of metabolites of ASP015K in plasma: AUCtau |  | Up to Day 12 | 
| PK parameter of metabolites of ASP015K in plasma: Cmax |  | Up to Day 12 | 
| PK parameter of metabolites of ASP015K in plasma: Ctrough |  | Up to Day 12 | 
| PK parameter of metabolites of ASP015K in plasma: PTR |  | Up to Day 12 | 
| PK parameter of metabolites of ASP015K in plasma: Rac |  | Up to Day 12 | 
| PK parameter of metabolites of ASP015K in plasma: t1/2 |  | Up to Day 12 | 
| PK parameter of metabolites of ASP015K in plasma: tmax |  | Up to Day 12 | 
| Safety assessed by Adverse events |  | Up to 17 days after first study drug dosing | 
| Number of participants with abnormal vital signs and/or adverse events related to treatment |  | Up to 17 days after first study drug dosing | 
| Number of participants with abnormal laboratory values and/or adverse events related to treatment |  | Up to 17 days after first study drug dosing | 
| Number of participants with abnormal standard 12-lead ECG and/or adverse events related to treatment | ECG: Electrocardiogram | Up to 17 days after first study drug dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Metformin, Drug-drug interaction, ASP015K