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

Astellas Pharma Inc24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

peficitinibDRUG

Oral

MetforminDRUG

Oral

Eligibility

Sex: MALEMin age: 20 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Site JP00001

Kagoshima, Japan

Outcomes

Primary Outcomes

Pharmacokinetics (PK) parameter of metformin in plasma: AUCinf

AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity

Time frame: Up to Day 12

PK parameter of metformin in plasma: Cmax

Cmax: Maximum concentration

Time frame: 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

Time frame: Up to Day 12

Secondary Outcomes

PK parameter of metformin in plasma: CL/F

CL/F: Apparent total systemic clearance

Time frame: Up to Day 12

PK parameter of metformin in plasma: t1/2

t1/2: Terminal elimination half-life

Time frame: Up to Day 12

PK parameter of metformin in plasma: tmax

tmax: Time of Cmax

Time frame: Up to Day 12

PK parameter of metformin in plasma: Vz/F

Vz/F: Apparent volume of distribution during the terminal elimination phase

Time frame: 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

Time frame: Up to Day 12

Data from ClinicalTrials.gov

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