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

Sponsor
Eisai Co., Ltd.
Study ID
NCT05278676
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 1, 2022
Status verified
Feb 2023
Primary completion
Dec 13, 2022
Completion
Dec 13, 2022

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.
  • 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.
  • 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.

Primary Outcome Measure

Single-dose Part, Cmax: Maximum Observed Concentration for Dotinurad [ Time Frame: Day 1: 0-48 hours post dose ]

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