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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP015K and Metformin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peficitinib | Drug | Oral |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP00001 | Kagoshima | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33068028 | Derived | Toyoshima J, Shibata M, Kaibara A, Kaneko Y, Izutsu H, Nishimura T. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis. Br J Clin Pharmacol. 2021 Apr;87(4):2014-2022. doi: 10.1111/bcp.14605. Epub 2020 Dec 1. |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| C000608065 | peficitinib |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin | Drug | Oral |
|
| 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 |