Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects

Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study ID
NCT06326723
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Daridorexant — DRUG
    25 mg group: Daridorexant group: strength 25 mg, administered at a dose of 25 mg; administered orally under fasting conditions, single dosing on Day1, and daily dosing on Day 4-8. Placebo control group: administered in the same manner as the test drug. 50 mg group: Daridorexant group: strength 50 mg, administered at a dose of 50 mg; administered orally under fasting conditions, single dosing on Day 1, and daily dosing on Day 4-8. Placebo control group: administered in the same manner as the test drug. Drug is to be administered at the same time every day, and the dosing window is recommended to be at 08:00 AM (±1 h) on the dosing day. Drinking water and other liquids should be avoided for 1 hour before and after dosing on the day of blood collection (except the water used to swallow the tablets.).

Study Details

This clinical study is a single-center, randomized, double-blind, placebo-controlled Phase 1 clinical study to assess the PK characteristics and safety and tolerability of single and multiple dose daridorexant in 32 healthy adult Chinese subjects.

Key Dates

Start date
Sep 4, 2023
Status verified
Feb 2024
Primary completion
Dec 24, 2023
Completion
Feb 5, 2024

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 25mg group
    Dose:25mg daridorexant or placebo Treatment Assignment :Day 1 SD, Day 4 - Day 8 MD (qdy) Number of subjects:16 (12 daridorexant + 4 placebo)
  • Experimental: 50mg group
    Dose:50mg daridorexant or placebo Treatment Assignment :Day 1 SD, Day 4 - Day 8 MD (qdy) Number of subjects:16 (12 daridorexant + 4 placebo)

Primary Outcome Measure

Pharmacokinetic Endpoints1 [ Time Frame: Day1-Day11 ]

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