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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-15

Study Completion Date

2016-06-26

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

peficitinib

Intervention Type DRUG

Oral

Metformin

Intervention Type DRUG

Oral

Interventions

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peficitinib

Oral

Intervention Type DRUG

Metformin

Oral

Intervention Type DRUG

Other Intervention Names

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ASP015K

Eligibility Criteria

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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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes