Skip to main content
OpenTrials
Completed

NCT Number: NCT02760342

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Site JP00001

Kagoshima, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

peficitinib

Drug

Oral

Other names: ASP015K

metformin

Drug

Oral

Primary outcomes

  1. Pharmacokinetics (PK) parameter of metformin in plasma: AUCinf

    Time frame: Up to Day 12

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

  2. PK parameter of metformin in plasma: Cmax

    Time frame: Up to Day 12

    Cmax: Maximum concentration

  3. PK parameter of metformin in plasma: AUClast

    Time frame: Up to Day 12

    AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration

Secondary outcomes

  1. PK parameter of metformin in plasma: CL/F

    Time frame: Up to Day 12

    CL/F: Apparent total systemic clearance

  2. PK parameter of metformin in plasma: t1/2

    Time frame: Up to Day 12

    t1/2: Terminal elimination half-life

  3. PK parameter of metformin in plasma: tmax

    Time frame: Up to Day 12

    tmax: Time of Cmax

  4. PK parameter of metformin in plasma: Vz/F

    Time frame: Up to Day 12

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

  5. PK parameter of metformin in urine: Aelast

    Time frame: Up to Day 12

    Aelast: Amount of metformin excreted into the urine from the time of dosing to the last measurable concentration

  6. PK parameter of metformin in urine: Aelast%

    Time frame: Up to Day 12

    Aelast%: Percent of metformin excreted into the urine from the time of dosing to the last measurable concentration

  7. PK parameter of metformin in urine: CLR

    Time frame: Up to Day 12

    CLR: Renal clearance

  8. PK parameter of ASP015K in plasma: AUCinf

    Time frame: Up to Day 12

  9. PK parameter of ASP015K in plasma: AUClast

    Time frame: Up to Day 12

  10. PK parameter of ASP015K in plasma: AUCtau

    Time frame: Up to Day 12

    AUCtau: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval

  11. PK parameter of ASP015K in plasma: CL/F

    Time frame: Up to Day 12

  12. PK parameter of ASP015K in plasma: Cmax

    Time frame: Up to Day 12

  13. PK parameter of ASP015K in plasma: Ctrough

    Time frame: Up to Day 12

    Ctrough: Concentration immediately prior to dosing at multiple dosing

  14. PK parameter of ASP015K in plasma: PTR

    Time frame: Up to Day 12

    PTR: Peak trough ratio

  15. PK parameter of ASP015K in plasma: Rac

    Time frame: Up to Day 12

    Rac: accumulation ratio

  16. PK parameter of ASP015K in plasma: t1/2

    Time frame: Up to Day 12

  17. PK parameter of ASP015K in plasma: tmax

    Time frame: Up to Day 12

  18. PK parameter of ASP015K in plasma: Vz/F

    Time frame: Up to Day 12

  19. PK parameter of metabolites of ASP015K in plasma: AUCinf

    Time frame: Up to Day 12

  20. PK parameter of metabolites of ASP015K in plasma: AUClast

    Time frame: Up to Day 12

  21. PK parameter of metabolites of ASP015K in plasma: AUCtau

    Time frame: Up to Day 12

  22. PK parameter of metabolites of ASP015K in plasma: Cmax

    Time frame: Up to Day 12

  23. PK parameter of metabolites of ASP015K in plasma: Ctrough

    Time frame: Up to Day 12

  24. PK parameter of metabolites of ASP015K in plasma: PTR

    Time frame: Up to Day 12

  25. PK parameter of metabolites of ASP015K in plasma: Rac

    Time frame: Up to Day 12

  26. PK parameter of metabolites of ASP015K in plasma: t1/2

    Time frame: Up to Day 12

  27. PK parameter of metabolites of ASP015K in plasma: tmax

    Time frame: Up to Day 12

  28. Safety assessed by Adverse events

    Time frame: Up to 17 days after first study drug dosing

  29. Number of participants with abnormal vital signs and/or adverse events related to treatment

    Time frame: Up to 17 days after first study drug dosing

  30. Number of participants with abnormal laboratory values and/or adverse events related to treatment

    Time frame: Up to 17 days after first study drug dosing

  31. Number of participants with abnormal standard 12-lead ECG and/or adverse events related to treatment

    Time frame: Up to 17 days after first study drug dosing

    ECG: Electrocardiogram

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 3, 2016
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.