Healthy Subjects
Conditions
Keywords
Pharmacokinetics, Metformin, Drug-drug interaction, ASP015K
Brief summary
The objective of this study is to evaluate the pharmacokinetic interactions between ASP015K and metformin in healthy non-elderly male subjects.
Interventions
DRUGpeficitinib
Oral
DRUGMetformin
Oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) parameter of metformin in plasma: AUCinf | Up to Day 12 | AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity |
| PK parameter of metformin in plasma: Cmax | Up to Day 12 | Cmax: Maximum concentration |
| PK parameter of metformin in plasma: AUClast | Up to Day 12 | AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter of metformin in plasma: Vz/F | Up to Day 12 | Vz/F: Apparent volume of distribution during the terminal elimination phase |
| PK parameter of metformin in urine: Aelast | Up to Day 12 | Aelast: Amount of metformin excreted into the urine from the time of dosing to the last measurable concentration |
| PK parameter of metformin in urine: Aelast% | Up to Day 12 | Aelast%: Percent of metformin excreted into the urine from the time of dosing to the last measurable concentration |
| PK parameter of metformin in urine: CLR | Up to Day 12 | CLR: Renal clearance |
| 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 | Up to Day 12 | AUCtau: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval |
| 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 | Up to Day 12 | Ctrough: Concentration immediately prior to dosing at multiple dosing |
| PK parameter of ASP015K in plasma: PTR | Up to Day 12 | PTR: Peak trough ratio |
| PK parameter of ASP015K in plasma: Rac | Up to Day 12 | Rac: accumulation ratio |
| 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 metformin in plasma: CL/F | Up to Day 12 | CL/F: Apparent total systemic clearance |
| 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 | Up to 17 days after first study drug dosing | ECG: Electrocardiogram |
| PK parameter of ASP015K in plasma: Vz/F | Up to Day 12 | — |
| PK parameter of metformin in plasma: t1/2 | Up to Day 12 | t1/2: Terminal elimination half-life |
| PK parameter of metformin in plasma: tmax | Up to Day 12 | tmax: Time of Cmax |
Countries
Japan
Outcome results
None listed