Clinical trial NCT02760342: A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Metformin
Official title: ASP015K Pharmacokinetic Study: Evaluation of Drug-Drug Interaction Between ASP015K and Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Pharmacokinetics
Metformin
Drug-drug interaction
ASP015K
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-05-03
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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).

Primary outcomes:
measure: Pharmacokinetics (PK) parameter of metformin in plasma: AUCinf
timeFrame: Up to Day 12
measure: PK parameter of metformin in plasma: Cmax
timeFrame: Up to Day 12
measure: PK parameter of metformin in plasma: AUClast
timeFrame: Up to Day 12
Secondary outcomes:
measure: PK parameter of metformin in plasma: CL/F
timeFrame: Up to Day 12
measure: PK parameter of metformin in plasma: t1/2
timeFrame: Up to Day 12
measure: PK parameter of metformin in plasma: tmax
timeFrame: Up to Day 12
measure: PK parameter of metformin in plasma: Vz/F
timeFrame: Up to Day 12
measure: PK parameter of metformin in urine: Aelast
timeFrame: Up to Day 12
measure: PK parameter of metformin in urine: Aelast%
timeFrame: Up to Day 12
measure: PK parameter of metformin in urine: CLR
timeFrame: Up to Day 12
measure: PK parameter of ASP015K in plasma: AUCinf
timeFrame: Up to Day 12
measure: PK parameter of ASP015K in plasma: AUClast
timeFrame: Up to Day 12
measure: PK parameter of ASP015K in plasma: AUCtau
timeFrame: Up to Day 12
measure: PK parameter of ASP015K in plasma: CL/F
timeFrame: Up to Day 12
measure: PK parameter of ASP015K in plasma: Cmax
timeFrame: Up to Day 12
measure: PK parameter of ASP015K in plasma: Ctrough
timeFrame: Up to Day 12
measure: PK parameter of ASP015K in plasma: PTR
timeFrame: Up to Day 12
measure: PK parameter of ASP015K in plasma: Rac
timeFrame: Up to Day 12
measure: PK parameter of ASP015K in plasma: t1/2
timeFrame: Up to Day 12
measure: PK parameter of ASP015K in plasma: tmax
timeFrame: Up to Day 12
measure: PK parameter of ASP015K in plasma: Vz/F
timeFrame: Up to Day 12
measure: PK parameter of metabolites of ASP015K in plasma: AUCinf
timeFrame: Up to Day 12
measure: PK parameter of metabolites of ASP015K in plasma: AUClast
timeFrame: Up to Day 12
measure: PK parameter of metabolites of ASP015K in plasma: AUCtau
timeFrame: Up to Day 12
measure: PK parameter of metabolites of ASP015K in plasma: Cmax
timeFrame: Up to Day 12
measure: PK parameter of metabolites of ASP015K in plasma: Ctrough
timeFrame: Up to Day 12
measure: PK parameter of metabolites of ASP015K in plasma: PTR
timeFrame: Up to Day 12
measure: PK parameter of metabolites of ASP015K in plasma: Rac
timeFrame: Up to Day 12
measure: PK parameter of metabolites of ASP015K in plasma: t1/2
timeFrame: Up to Day 12
measure: PK parameter of metabolites of ASP015K in plasma: tmax
timeFrame: Up to Day 12
measure: Safety assessed by Adverse events
timeFrame: Up to 17 days after first study drug dosing
measure: Number of participants with abnormal vital signs and/or adverse events related to treatment
timeFrame: Up to 17 days after first study drug dosing
measure: Number of participants with abnormal laboratory values and/or adverse events related to treatment
timeFrame: Up to 17 days after first study drug dosing
measure: Number of participants with abnormal standard 12-lead ECG and/or adverse events related to treatment
timeFrame: Up to 17 days after first study drug dosing
Other outcomes:
Locations:
city: Kagoshima
country: Japan
facility: Site JP00001
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.