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

NCT06326723 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-03-22

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Daridorexant

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.).

Sponsors & Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Juan Li · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-04
Primary Completion
2023-12-24
Completion
2024-02-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06326723 on ClinicalTrials.gov