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

October 15, 2024 updated by: Astellas Pharma Inc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kagoshima, Japan
        • Site JP00001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: peficitinib
Oral
Other Names:
  • ASP015K
Drug: Metformin
Oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Up to Day 12
PK parameter of metformin in plasma: Cmax
Time Frame: Up to Day 12
Cmax: Maximum concentration
Up to Day 12
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
Up to Day 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PK parameter of metformin in plasma: CL/F
Time Frame: Up to Day 12
CL/F: Apparent total systemic clearance
Up to Day 12
PK parameter of metformin in plasma: t1/2
Time Frame: Up to Day 12
t1/2: Terminal elimination half-life
Up to Day 12
PK parameter of metformin in plasma: tmax
Time Frame: Up to Day 12
tmax: Time of Cmax
Up to Day 12
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
Up to Day 12
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
Up to Day 12
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
Up to Day 12
PK parameter of metformin in urine: CLR
Time Frame: Up to Day 12
CLR: Renal clearance
Up to Day 12
PK parameter of ASP015K in plasma: AUCinf
Time Frame: Up to Day 12
Up to Day 12
PK parameter of ASP015K in plasma: AUClast
Time Frame: Up to Day 12
Up to Day 12
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
Up to Day 12
PK parameter of ASP015K in plasma: CL/F
Time Frame: Up to Day 12
Up to Day 12
PK parameter of ASP015K in plasma: Cmax
Time Frame: Up to Day 12
Up to Day 12
PK parameter of ASP015K in plasma: Ctrough
Time Frame: Up to Day 12
Ctrough: Concentration immediately prior to dosing at multiple dosing
Up to Day 12
PK parameter of ASP015K in plasma: PTR
Time Frame: Up to Day 12
PTR: Peak trough ratio
Up to Day 12
PK parameter of ASP015K in plasma: Rac
Time Frame: Up to Day 12
Rac: accumulation ratio
Up to Day 12
PK parameter of ASP015K in plasma: t1/2
Time Frame: Up to Day 12
Up to Day 12
PK parameter of ASP015K in plasma: tmax
Time Frame: Up to Day 12
Up to Day 12
PK parameter of ASP015K in plasma: Vz/F
Time Frame: Up to Day 12
Up to Day 12
PK parameter of metabolites of ASP015K in plasma: AUCinf
Time Frame: Up to Day 12
Up to Day 12
PK parameter of metabolites of ASP015K in plasma: AUClast
Time Frame: Up to Day 12
Up to Day 12
PK parameter of metabolites of ASP015K in plasma: AUCtau
Time Frame: Up to Day 12
Up to Day 12
PK parameter of metabolites of ASP015K in plasma: Cmax
Time Frame: Up to Day 12
Up to Day 12
PK parameter of metabolites of ASP015K in plasma: Ctrough
Time Frame: Up to Day 12
Up to Day 12
PK parameter of metabolites of ASP015K in plasma: PTR
Time Frame: Up to Day 12
Up to Day 12
PK parameter of metabolites of ASP015K in plasma: Rac
Time Frame: Up to Day 12
Up to Day 12
PK parameter of metabolites of ASP015K in plasma: t1/2
Time Frame: Up to Day 12
Up to Day 12
PK parameter of metabolites of ASP015K in plasma: tmax
Time Frame: Up to Day 12
Up to Day 12
Safety assessed by Adverse events
Time Frame: Up to 17 days after first study drug dosing
Up to 17 days after first study drug dosing
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
Up to 17 days after first study drug dosing
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
Up to 17 days after first study drug dosing
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
Up to 17 days after first study drug dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 26, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 015K-CL-PK20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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/.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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