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

Eisai logo

Eisai

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Dotinurad

Study type

Interventional

Funder types

Industry

Identifiers

NCT05278676
FYU-981-J086-001

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 3 patient groups

Cohort A Single Dose: Dotinurad
Experimental group
Description:
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.
Treatment:
Drug: Dotinurad
Cohort B Multiple Dose: Dotinurad
Experimental group
Description:
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.
Treatment:
Drug: Dotinurad
Cohort C Single Dose: Dotinurad
Experimental group
Description:
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.
Treatment:
Drug: Dotinurad

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems