A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Metformin
- Registration Number
- NCT02760342
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The objective of this study is to evaluate the pharmacokinetic interactions between ASP015K and metformin in healthy non-elderly male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ASP015K and Metformin peficitinib 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. ASP015K and Metformin Metformin 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 ASP015K in plasma: Ctrough Up to Day 12 Ctrough: Concentration immediately prior to dosing at multiple dosing
PK parameter of metabolites of ASP015K in plasma: AUCinf 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: t1/2 Up to Day 12 Number of participants with abnormal vital signs and/or adverse events related to treatment Up to 17 days after first study drug dosing 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 metformin in plasma: t1/2 Up to Day 12 t1/2: Terminal elimination half-life
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%: Percent of metformin excreted into the urine from the time of dosing to the last measurable concentration
PK parameter of ASP015K in plasma: AUCinf Up to Day 12 PK parameter of ASP015K in plasma: Vz/F Up to Day 12 Safety assessed by Adverse events 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 metformin in plasma: tmax Up to Day 12 tmax: Time of Cmax
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 ASP015K in plasma: AUClast Up to Day 12 PK parameter of ASP015K in plasma: PTR Up to Day 12 PTR: Peak trough ratio
PK parameter of metabolites of ASP015K in plasma: tmax Up to Day 12 PK parameter of metformin in urine: CLR Up to Day 12 CLR: Renal clearance
PK parameter of metabolites of ASP015K in plasma: AUClast Up to Day 12 PK parameter of metabolites of ASP015K in plasma: Rac Up to Day 12 PK parameter of ASP015K in plasma: CL/F 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 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: Cmax Up to Day 12
Trial Locations
- Locations (1)
Site JP00001
🇯🇵Kagoshima, Japan