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Completed

NCT Number: NCT05278676

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui District Central Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Healthy Chinese participants living in China.
  • 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.
  • Participants with serum uric acid level less than >=5.5 milligrams per decilitre (mg/dL) at Screening (Cohort B only).

Key Exclusion Criteria:

  • 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.
  • Females of childbearing potential.
  • Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
  • 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.
  • Any history of gastrointestinal surgery that may affect PK profiles of dotinurad, example, hepatectomy, nephrectomy, digestive organ resection at Screening.

Treatment and study plan

Dotinurad

Drug

Dotinurad oral tablet.

Other names: FYU-981

Primary outcomes

  1. Single-dose Part, Cmax: Maximum Observed Concentration for Dotinurad

    Time frame: Day 1: 0-48 hours post dose

  2. Single-dose Part, Tmax: Time at Which the Highest Drug Concentration Occurs for Dotinurad

    Time frame: Day 1: 0-48 hours post dose

  3. Single-dose Part, t1/2: Terminal Elimination Phase Half-life for Dotinurad

    Time frame: Day 1: 0-48 hours post dose

  4. 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

  5. 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

  6. 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

  7. Single-dose Part, CL/F: Apparent Total Clearance Following Oral Administration for Dotinurad

    Time frame: Day 1: 0-48 hours post dose

  8. Single-dose Part, Vz/F: Apparent Volume of Distribution at Terminal Phase for Dotinurad

    Time frame: Day 1: 0-48 hours post dose

  9. Single-dose Part, kel: Elimination Rate Constant for Dotinurad

    Time frame: Day 1: 0-48 hours post dose

  10. 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

  11. Multiple-dose Part, Css,max: Maximum Observed Concentration at Steady State for Dotinurad

    Time frame: Day 10: 0-72 hours post dose

  12. Multiple-dose Part, Css,min: Minimum Observed Concentration at Steady State for Dotinurad

    Time frame: Day 10: 0-72 hours post dose

  13. Multiple-dose Part, Css,av: Average Steady-state Concentration for Dotinurad

    Time frame: Day 10: 0-72 hours post dose

  14. 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

  15. Multiple-dose Part, t1/2: Terminal Elimination Phase Half-life for Dotinurad

    Time frame: Day 10: 0-72 hours post dose

  16. 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

  17. 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

  18. Multiple-dose Part, Vz/F: Apparent Volume of Distribution at Terminal Phase for Dotinurad

    Time frame: Day 10: 0-72 hours post dose

  19. Multiple-dose Part, kel: Elimination Rate Constant for Dotinurad

    Time frame: Day 10: 0-72 hours post dose

  20. Multiple-dose Part, MRT: Mean Residence Time for Dotinurad

    Time frame: Day 10: 0-72 hours post dose

  21. Multiple-dose Part, Rac(AUC0-24h): Accumulation Ratio for AUC(0-24h)

    Time frame: Day 10: 0-24 hours post dose

  22. Multiple-dose Part, Rac(Cmax): Accumulation Ratio for Cmax

    Time frame: Day 10: 0-72 hours post dose

  23. Multiple-dose Part, PTF: Peak-trough Fluctuation

    Time frame: Day 10: 0-72 hours post dose

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2022
Registry last updated
Sep 14, 2023

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.

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