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Healthy SubjectsPhase 1NCT02760342

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

A Phase 1 study testing peficitinib and Metformin in people with Healthy Subjects, run by Astellas Pharma Inc at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 44 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
peficitinib and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteJapan
Study dates
15 May 2016to 26 Jun 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 44 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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 locations and contacts

1 site in 1 country.

Japan1 site

  • Site JP00001

    Kagoshima

Other trials in Japan

About this study

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

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

Being tested
peficitinib, Metformin
Keywords
Pharmacokinetics, Metformin, Drug-drug interaction, ASP015K

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • peficitinibDrug

    Also called ASP015K

    Oral

  • MetforminDrug

    Oral

Study groups in NCT02760342
Study groupRoleWhat they receive
ASP015K and MetforminExperimentalSubjects 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.
Receives: Drug: peficitinib; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Up to Day 12

  2. PK parameter of metformin in plasma: Cmax

    Cmax: Maximum concentration

    Measured: Up to Day 12

  3. PK parameter of metformin in plasma: AUClast

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

    Measured: Up to Day 12

Secondary outcomes (31)

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

    CL/F: Apparent total systemic clearance

    Measured: Up to Day 12

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

    t1/2: Terminal elimination half-life

    Measured: Up to Day 12

  3. PK parameter of metformin in plasma: tmax

    tmax: Time of Cmax

    Measured: Up to Day 12

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

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

    Measured: Up to Day 12

  5. 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

    Measured: Up to Day 12

  6. PK parameter of metformin in urine: Aelast%

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

    Measured: Up to Day 12

  7. PK parameter of metformin in urine: CLR

    CLR: Renal clearance

    Measured: Up to Day 12

  8. PK parameter of ASP015K in plasma: AUCinf

    Measured: Up to Day 12

  9. PK parameter of ASP015K in plasma: AUClast

    Measured: Up to Day 12

  10. PK parameter of ASP015K in plasma: AUCtau

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

    Measured: Up to Day 12

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

    Measured: Up to Day 12

  12. PK parameter of ASP015K in plasma: Cmax

    Measured: Up to Day 12

  13. PK parameter of ASP015K in plasma: Ctrough

    Ctrough: Concentration immediately prior to dosing at multiple dosing

    Measured: Up to Day 12

  14. PK parameter of ASP015K in plasma: PTR

    PTR: Peak trough ratio

    Measured: Up to Day 12

  15. PK parameter of ASP015K in plasma: Rac

    Rac: accumulation ratio

    Measured: Up to Day 12

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

    Measured: Up to Day 12

  17. PK parameter of ASP015K in plasma: tmax

    Measured: Up to Day 12

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

    Measured: Up to Day 12

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

    Measured: Up to Day 12

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

    Measured: Up to Day 12

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

    Measured: Up to Day 12

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

    Measured: Up to Day 12

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

    Measured: Up to Day 12

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

    Measured: Up to Day 12

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

    Measured: Up to Day 12

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

    Measured: Up to Day 12

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

    Measured: Up to Day 12

  28. Safety assessed by Adverse events

    Measured: Up to 17 days after first study drug dosing

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

    Measured: Up to 17 days after first study drug dosing

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

    Measured: 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

    ECG: Electrocardiogram

    Measured: Up to 17 days after first study drug dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2016 (estimated)
  2. Study start15 May 2016
  3. Primary completion26 Jun 2016
  4. Study completion26 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02760342
Sponsor's protocol ID
015K-CL-PK20
Status last verified
Sep 2019
First submitted
1 May 2016
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Toyoshima J, Shibata M, Kaibara A, Kaneko Y, Izutsu H, Nishimura T. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis. Br J Clin Pharmacol. 2021 Apr;87(4):2014-2022. doi: 10.1111/bcp.14605. Epub 2020 Dec 1.

    PubMed 33068028

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing peficitinib and Metformin in people with Healthy Subjects, run by Astellas Pharma Inc at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK) parameter of metformin in plasma: AUCinf (time frame: Up to Day 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02760342, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.

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