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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT02760342

Collaborator

(none)

Enrollment

Location

Arm

1.4

Actual Duration (Months)

17.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: peficitinib Drug: Metformin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 15, 2016

Actual Primary Completion Date :

Jun 26, 2016

Actual Study Completion Date :

Jun 26, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP015K and 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.	Drug: peficitinib Oral Other Names: ASP015K Drug: Metformin Oral

Arm

Intervention/Treatment

Experimental: ASP015K and 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.

Drug: peficitinib

Oral

Other Names:

ASP015K

Drug: Metformin

Oral

Outcome Measures

Primary Outcome Measures

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

PK parameter of metformin in plasma: CL/F [Up to Day 12]
CL/F: Apparent total systemic clearance
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
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 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 [Up to 17 days after first study drug dosing]
ECG: Electrocardiogram

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 44 Years

Sexes Eligible for Study:

Male

Accepts 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).