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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-12-13

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dotinurad

Intervention Type DRUG

Dotinurad oral tablet.

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.

Group Type EXPERIMENTAL

Dotinurad

Intervention Type DRUG

Dotinurad oral tablet.

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.

Group Type EXPERIMENTAL

Dotinurad

Intervention Type DRUG

Dotinurad oral tablet.

Interventions

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Dotinurad

Dotinurad oral tablet.

Intervention Type DRUG

Other Intervention Names

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FYU-981

Eligibility Criteria

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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).

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes