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

NCT06326723 | Completed Phase 1

• 1 other identifier: SIM0808-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (7)

• Pharmacokinetic Endpoints1

  Maximum plasma concentration (Cmax)

  Day1-Day11

• Pharmacokinetic Endpoints2

  Area under the concentration-time curve from zero to 24 hours (AUC0-24)

  Day1-Day11

• Pharmacokinetic Endpoints3

  Aarea under the concentration-time curve from zero to 48 hours (AUC0-48)

  Day1-Day11

• Pharmacokinetic Endpoints4

  Area under the concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t)

  Day1-Day11

• Pharmacokinetic Endpoints5

  area under the concentration-time curve from zero to infinity (AUC0-∞)

  Day1-Day11

• Pharmacokinetic Endpoints6

  Time to reach maximum concentration (Tmax)

  Day1-Day11

• Pharmacokinetic Endpoints7

  Terminal half-life (t1/2), and accumulation index (AI)

  Day1-Day11

Secondary Outcomes (8)

• Safety Endpoints1

  Day1-Day11

• Safety Endpoints2

  Day1-Day11

• Safety Endpoints3

  Day1-Day38

• Safety Endpoints4

  Day1-Day38

• Safety Endpoints5

  Day1-Day38

Study Arms (2)

25mg group

EXPERIMENTAL

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

Drug: Daridorexant

50mg group

EXPERIMENTAL

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

Drug: Daridorexant

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.).

25mg group; 50mg group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study. Signed informed consent in the local language prior to any study-mandated procedure.
• Healthy Chinese male or female subjects aged between 18 and 55 years (inclusive) at screening.
• Body Mass Index (BMI) ≥ 19 and ≤ 26 kg/m2, weight at least 45 kg for female, weight at least 50 kg for male at screening.
• General good health at screening, with no abnormalities or abnormal clinically insignificant results based on medical history and physical examination, vital signs, laboratory tests, and 12-lead ECG performed at the time of screening. 50 bpm≤Resting heart rate (HR)≤100 bpm, 90mmHg \<systolic blood pressure\<140 mmHg or 50 mmHg\<diastolic blood pressure\<90 mmHg, ECG evidence of a QTcF interval of no more than 450 ms for male, ECG evidence of a QTcF interval of no more than 470 ms for female, (ECG monitors will be conducted for three times in five minutes, and mean values of three monitor results will be used)
• Negative results from alcohol breath test and urine drug screen at Day -1.
• Subjects (including male subjects) are willing to voluntarily use effective contraception from screening visit until 30 days after the end of the last dose and had no plans to become pregnant, planned parenthood or sperm/egg donation plans; Or subjects after surgical sterilization, or postmenopausal female subjects (female subjects with natural menopause ≥12 months can be considered postmenopausal; If age \<50 years by follicle stimulating hormone level confirmed)

You may not qualify if:

• Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
• Intubation or repeat venipuncture is not appropriate.
• Treatment with any prescription medications or over-the-counter medications (including herbal medicines) within 14 days prior to (first) study drug administration.
• Have received any vaccine (including COVID-19 vaccine) prior to screening; have plan to receive vaccine (COVID-19 vaccine) during the study period or within 30 days after the last dose.
• Not able or willing to stop treatment with moderate or strong cytochrome P450 (CYP)3A4 inhibitors, or treatment with moderate or strong CYP3A4 inducers, within 14 days prior to (first) study drug administration.
• Not able or willing to stop consumption of grapefruit, Seville (bitter) oranges or juices from those fruits within 14 days prior to (first) study drug administration.
• Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening.
• Use any nicotine or tobacco containing products (\>5 cigarettes/day) within 3 years prior to day 1 and inability to refrain from smoking during the study.
• Alcohol abuse（≥ 14 standard drinks units per week; 1 unit: 285 mL beer or 25 mL spirits or 100 mL wine） within 3 years prior to day 1 and inability to refrain from taking alcohol during the study.
• Drinking excessive tea (\>15 g tea leaves/day; 1 cup of tea contains about 3\~5 g of tea leaves) or caffeine (\>500 mg/ day, 1 cup of coffee contains about 85 mg of caffeine) and inability to refrain from drinking tea or caffeinated beverage during the study.
• History or clinical evidence of any disease, and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study drugs (appendectomy and herniotomy allowed; cholecystectomy not allowed).
• History of drug abuse.
• Loss of 400 mL or more of blood, or an equivalent amount of plasma, within 3 months prior to screening.
• Positive result to any of the following tests: HIV, hepatitis B, hepatitis C, and syphilis.
• Known hypersensitivity to any excipients of the drug formulations.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Nanjing Drum Tower hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Interventions

daridorexant

Study Officials

• Juan Li

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: March 22, 2024
• Study Start: September 4, 2023
• Primary Completion: December 24, 2023
• Study Completion: February 5, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)