CompletedNCT05278676Updated Sep 14, 2023

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

A Phase 1 interventional study of Dotinurad in Healthy Volunteers, sponsored by Eisai Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by Eisai Co., Ltd. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 26
Allocation: Non-randomized
Ages: 18 Years to 45 Years
Sex: All

Study summary

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.

Conditions studied

Healthy Volunteers

In context

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 26 participants (actual)

Study arms

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
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
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

Interventions

DrugDotinurad
Dotinurad oral tablet.
Also known as: FYU-981

What researchers measure

Primary outcomes

Single-dose Part, Cmax: Maximum Observed Concentration for Dotinurad
Time frame: 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
Single-dose Part, t1/2: Terminal Elimination Phase Half-life for Dotinurad
Time frame: 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
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
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
Single-dose Part, CL/F: Apparent Total Clearance Following Oral Administration for Dotinurad
Time frame: 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
Single-dose Part, kel: Elimination Rate Constant for Dotinurad
Time frame: 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
Multiple-dose Part, Css,max: Maximum Observed Concentration at Steady State for Dotinurad
Time frame: 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
Multiple-dose Part, Css,av: Average Steady-state Concentration for Dotinurad
Time frame: 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
Multiple-dose Part, t1/2: Terminal Elimination Phase Half-life for Dotinurad
Time frame: 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
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
Multiple-dose Part, Vz/F: Apparent Volume of Distribution at Terminal Phase for Dotinurad
Time frame: 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
Multiple-dose Part, MRT: Mean Residence Time for Dotinurad
Time frame: 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
Multiple-dose Part, Rac(Cmax): Accumulation Ratio for Cmax
Time frame: Day 10: 0-72 hours post dose
Multiple-dose Part, PTF: Peak-trough Fluctuation
Time frame: Day 10: 0-72 hours post dose

Study locations

1 site

Shanghai Xuhui District Central Hospital
Shanghai, China

References and documents

Individual participant data

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

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05278676
Lead sponsor: Eisai Co., Ltd.
Responsible party: Sponsor
First posted: Mar 14, 2022
Start date: Jul 1, 2022
Primary completion: Dec 13, 2022
Completion: Dec 13, 2022
Last update: Sep 14, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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