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

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Metformin; Drug: peficitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02760342

015K-CL-PK20

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

ASP015K and Metformin

Experimental group

Description:

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.

Treatment:

Drug: peficitinib

Drug: Metformin