A Single and Multiple Dose Study of Dotinurad in Chinese Healthy Participants

September 13, 2023 updated by: Eisai Co., Ltd.

A Single and Multiple Dose Pharmacokinetic Study of Dotinurad in Chinese Healthy Subjects

The primary purpose of this study is to evaluate the pharmacokinetics (PK) of dotinurad following single and multiple oral doses of dotinurad in Chinese healthy male and female participants.

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.
26

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

  • China
      • Shanghai, China
        • Shanghai Xuhui District Central Hospital

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  1. Healthy Chinese participants living in China.
  2. Non-smoking, male or female, age greater than or equal to (>=) 18 years and less than or equal to (<=) 45 years old at the time of informed consent.
  3. Participants with serum uric acid level less than >=5.5 milligrams per decilitre (mg/dL) at Screening (Cohort B only).

Key Exclusion Criteria:

  1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] or human chorionic gonadotropin [hCG] test). A separate baseline assessment of serum β-hCG (or hCG) or urine pregnancy test is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
  2. Females of childbearing potential.
  3. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
  4. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism.
  5. Any history of gastrointestinal surgery that may affect PK profiles of dotinurad, example, hepatectomy, nephrectomy, digestive organ resection at Screening.

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: Non-Randomized
  • Interventional Model: Parallel 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: Cohort A Single Dose: Dotinurad
Participants will receive dotinurad 1 milligram (mg) (1*1 mg tablet) as a single oral dose after 10-hour fasting on Day 1 in the morning.
Drug: Dotinurad
Dotinurad oral tablet.
Other Names:
  • FYU-981
Experimental: Cohort B Multiple Dose: Dotinurad
Participants will receive dotinurad 4 mg (2*2 mg tablets) as a single oral dose after 10-hour fasting on Day 1 in the morning. A washout period of 3 days will be maintained after single dose on Day 1 and then participants will receive dotinurad 4 mg (2*2 mg tablets) after 10-hour fasting from Day 4 to Day 10 once daily in the morning.
Drug: Dotinurad
Dotinurad oral tablet.
Other Names:
  • FYU-981
Experimental: Cohort C Single Dose: Dotinurad
Participants will receive dotinurad 10 mg (5*2 mg tablets) as a single oral dose after 10-hour fasting on Day 1 in the morning.
Drug: Dotinurad
Dotinurad oral tablet.
Other Names:
  • FYU-981

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
Time Frame
Single-dose Part, Cmax: Maximum Observed Concentration for Dotinurad
Time Frame: Day 1: 0-48 hours post dose
Day 1: 0-48 hours post dose
Single-dose Part, Tmax: Time at Which the Highest Drug Concentration Occurs for Dotinurad
Time Frame: Day 1: 0-48 hours post dose
Day 1: 0-48 hours post dose
Single-dose Part, t1/2: Terminal Elimination Phase Half-life for Dotinurad
Time Frame: Day 1: 0-48 hours post dose
Day 1: 0-48 hours post dose
Single-dose Part, AUC0-t: Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for Dotinurad
Time Frame: Day 1: 0-48 hours post dose
Day 1: 0-48 hours post dose
Single-dose Part, AUC0-24h: Area Under the Concentration-time Curve From Zero Time to 24 hours for Dotinurad
Time Frame: Day 1: 0-24 hours post dose
Day 1: 0-24 hours post dose
Single-dose Part, AUC0-inf: Area Under the Concentration-time Curve From Zero Time Extrapolated to Infinite Time for Dotinurad
Time Frame: Day 1: 0-48 hours post dose
Day 1: 0-48 hours post dose
Single-dose Part, CL/F: Apparent Total Clearance Following Oral Administration for Dotinurad
Time Frame: Day 1: 0-48 hours post dose
Day 1: 0-48 hours post dose
Single-dose Part, Vz/F: Apparent Volume of Distribution at Terminal Phase for Dotinurad
Time Frame: Day 1: 0-48 hours post dose
Day 1: 0-48 hours post dose
Single-dose Part, kel: Elimination Rate Constant for Dotinurad
Time Frame: Day 1: 0-48 hours post dose
Day 1: 0-48 hours post dose
Single-dose Part, MRT0-t: Mean Residence Time From Zero Time to Time of Last Quantifiable Concentration on Single Dose for Dotinurad
Time Frame: Day 1: 0-48 hours post dose
Day 1: 0-48 hours post dose
Multiple-dose Part, Css,max: Maximum Observed Concentration at Steady State for Dotinurad
Time Frame: Day 10: 0-72 hours post dose
Day 10: 0-72 hours post dose
Multiple-dose Part, Css,min: Minimum Observed Concentration at Steady State for Dotinurad
Time Frame: Day 10: 0-72 hours post dose
Day 10: 0-72 hours post dose
Multiple-dose Part, Css,av: Average Steady-state Concentration for Dotinurad
Time Frame: Day 10: 0-72 hours post dose
Day 10: 0-72 hours post dose
Multiple-dose Part, tss,max: Time at Which the Highest Drug Concentration Occurs at Steady State for Dotinurad
Time Frame: Day 10: 0-72 hours post dose
Day 10: 0-72 hours post dose
Multiple-dose Part, t1/2: Terminal Elimination Phase Half-life for Dotinurad
Time Frame: Day 10: 0-72 hours post dose
Day 10: 0-72 hours post dose
Multiple-dose Part, AUC0-τ: Area Under the Concentration-time Curve Over the Dosing Interval on Multiple Dosing for Dotinurad
Time Frame: Day 10: 0-72 hours post dose
Day 10: 0-72 hours post dose
Multiple-dose Part, CLss/F: Apparent Total Clearance Following Oral Administration at Steady State for Dotinurad
Time Frame: Day 10: 0-72 hours post dose
Day 10: 0-72 hours post dose
Multiple-dose Part, Vz/F: Apparent Volume of Distribution at Terminal Phase for Dotinurad
Time Frame: Day 10: 0-72 hours post dose
Day 10: 0-72 hours post dose
Multiple-dose Part, kel: Elimination Rate Constant for Dotinurad
Time Frame: Day 10: 0-72 hours post dose
Day 10: 0-72 hours post dose
Multiple-dose Part, MRT: Mean Residence Time for Dotinurad
Time Frame: Day 10: 0-72 hours post dose
Day 10: 0-72 hours post dose
Multiple-dose Part, Rac(AUC0-24h): Accumulation Ratio for AUC(0-24h)
Time Frame: Day 10: 0-24 hours post dose
Day 10: 0-24 hours post dose
Multiple-dose Part, Rac(Cmax): Accumulation Ratio for Cmax
Time Frame: Day 10: 0-72 hours post dose
Day 10: 0-72 hours post dose
Multiple-dose Part, PTF: Peak-trough Fluctuation
Time Frame: Day 10: 0-72 hours post dose
Day 10: 0-72 hours post dose

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.
Eisai Co., Ltd.

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.
July 1, 2022

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.
December 13, 2022

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.
December 13, 2022

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).
February 18, 2022

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.
March 4, 2022

First Posted (Actual)

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.
March 14, 2022

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.
September 14, 2023

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.
September 13, 2023

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.
February 1, 2023

More Information

Terms related to this study

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.
  • FYU-981-J086-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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