Healthy VolunteerPhase 1NCT06326723
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
A Phase 1 study testing Daridorexant in people with Healthy Volunteer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Daridorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2023to 5 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 23Show fewer
- 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.
- Modified Swiss Narcolepsy Scale total score < 0 at screening. History of narcolepsy or cataplexy.
- Any surgery planned during the study period.
- Legal incapacity or limited legal capacity at screening
- History of tuberculosis (TB).
- Pregnant or lactating women, or positive pregnancy test results.
- Any suicidal ideation with intent, with or without a plan (at screening):
- Planned or unplanned any suicidal thoughts; That is, answer yes to question 4 or 5 of the Suicidal ideation section of the lifetime version C-SSRS©. Lifetime past C-SSRS© Suicidal Behavior section indicates a history of suicide attempts.
- Any circumstances or conditions which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Investigate the Pharmacokinetics, Safety, and Tolerability After Single- and Multiple-Dose Daridorexant in Chinese Healthy Subjects
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.
Read the detailed description
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 healthy adult Chinese subjects. This study will consist of a 20-day screening period, a 1-day baseline, a 11-day in patient period, and a 27-day follow-up period. The subjects will arrive at the study site on Day -1, and the subjects will be discharged from the study site on Day11.
32 healthy subjects (18-55 years) will be randomized. Two dose levels are planned (25 mg and 50 mg). 16 healthy subjects will be randomized with a ratio of 3:1 to receive 25mg daridorexant or matched placebo and another 16 healthy subjects will be randomized with a ratio of 3:1 to receive 50mg daridorexant or matched placebo. On Day 1, each subject will receive a single dose of daridorexant or placebo in the morning under fast conditions and PK samples will be collected up to 72 h post dose. Subject will receive repeated doses of daridorexant or placebo from day 4 to day 8 (QD) in the morning under fasting conditions and PK samples will be collected up to 72 h post last dose. The final follow-up visit will be conducted on Day 38, 30 days after the last dose.
- Conditions
- Healthy Volunteer
- Being tested
- Daridorexant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaridorexantDrug
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Daridorexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Endpoints1
Maximum plasma concentration (Cmax)
Measured: Day1-Day11
Pharmacokinetic Endpoints2
Area under the concentration-time curve from zero to 24 hours (AUC0-24)
Measured: Day1-Day11
Pharmacokinetic Endpoints3
Aarea under the concentration-time curve from zero to 48 hours (AUC0-48)
Measured: 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)
Measured: Day1-Day11
Pharmacokinetic Endpoints5
area under the concentration-time curve from zero to infinity (AUC0-∞)
Measured: Day1-Day11
Pharmacokinetic Endpoints6
Time to reach maximum concentration (Tmax)
Measured: Day1-Day11
Pharmacokinetic Endpoints7
Terminal half-life (t1/2), and accumulation index (AI)
Measured: Day1-Day11
Secondary outcomes (8)
Safety Endpoints1
Number and proportion of subjects with treatment-emergent adverse events
Measured: Day1-Day11
Safety Endpoints2
Number and proportion of subjects with treatment-emergent serious adverse events
Measured: Day1-Day11
Safety Endpoints3
Clinically significant vital sign abnormalities after the first dose of study drug up to 30 days after the last dose
Measured: Day1-Day38
Safety Endpoints4
Clinically significant physical examination abnormalities after the first dose of study drug up to 30 days after the last dose
Measured: Day1-Day38
Safety Endpoints5
Clinically significant blood routine test abnormalities after the first dose of study drug up to 30 days after the last dose
Measured: Day1-Day38
Safety Endpoints6
Clinically significant urinalysis abnormalities after the first dose of study drug up to 30 days after the last dose
Measured: Day1-Day38
Safety Endpoints7
Clinically significant abnormal blood biochemistry from the first dose of the study drug to 30 days after the last dose
Measured: Day1-Day38
Safety Endpoints8
Clinically significant ECG changes after the first dose of study drug up to 30 days after the last dose
Measured: Day1-Day38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start4 Sep 2023
- Primary completion24 Dec 2023
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Li, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326723
- Sponsor's protocol ID
- SIM0808-101
- Status last verified
- Feb 2024
- First submitted
- 17 Feb 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Investigate the Pharmacokinetics, Safety, and Tolerability After Single- and Multiple-Dose Daridorexant in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06326723
- Acronym / sponsor ID
- SIM0808-101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 24 Dec 2023 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 healthy adult Chinese subjects. This study will consist of a 20-day screening period, a 1-day baseline, a 11-day in patient period, and a 27-day follow-up period. The subjects will arrive at the study site on Day -1, and the subjects will be discharged from the study site on Day11.
32 healthy subjects (18-55 years) will be randomized. Two dose levels are planned (25 mg and 50 mg). 16 healthy subjects will be randomized with a ratio of 3:1 to receive 25mg daridorexant or matched placebo and another 16 healthy subjects will be randomized with a ratio of 3:1 to receive 50mg daridorexant or matched placebo. On Day 1, each subject will receive a single dose of daridorexant or placebo in the morning under fast conditions and PK samples will be collected up to 72 h post dose. Subject will receive repeated doses of daridorexant or placebo from day 4 to day 8 (QD) in the morning under fasting conditions and PK samples will be collected up to 72 h post last dose. The final follow-up visit will be conducted on Day 38, 30 days after the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25mg group | Experimental | Drug: DaridorexantDose:25mg daridorexant or placebo Treatment Assignment :Day 1 SD, Day 4 - Day 8 MD (qdy) Number of subjects:16 (12 daridorexant + 4 placebo) |
| 50mg group | Experimental | Drug: DaridorexantDose:50mg daridorexant or placebo Treatment Assignment :Day 1 SD, Day 4 - Day 8 MD (qdy) Number of subjects:16 (12 daridorexant + 4 placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daridorexant25 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.). | Drug | 25mg group, 50mg group |
Primary outcome
Pharmacokinetic Endpoints1
Time frame: Day1-Day11
Maximum plasma concentration (Cmax)
Pharmacokinetic Endpoints2
Time frame: Day1-Day11
Area under the concentration-time curve from zero to 24 hours (AUC0-24)
Pharmacokinetic Endpoints3
Time frame: Day1-Day11
Aarea under the concentration-time curve from zero to 48 hours (AUC0-48)
Pharmacokinetic Endpoints4
Time frame: Day1-Day11
Area under the concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
Pharmacokinetic Endpoints5
Time frame: Day1-Day11
area under the concentration-time curve from zero to infinity (AUC0-∞)
Pharmacokinetic Endpoints6
Time frame: Day1-Day11
Time to reach maximum concentration (Tmax)
Pharmacokinetic Endpoints7
Time frame: Day1-Day11
Terminal half-life (t1/2), and accumulation index (AI)
8 secondary outcomes
Safety Endpoints1
Time frame: Day1-Day11
Safety Endpoints2
Time frame: Day1-Day11
Safety Endpoints3
Time frame: Day1-Day38
Safety Endpoints4
Time frame: Day1-Day38
Safety Endpoints5
Time frame: Day1-Day38
Safety Endpoints6
Time frame: Day1-Day38
Safety Endpoints7
Time frame: Day1-Day38
Safety Endpoints8
Time frame: Day1-Day38
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Li principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Daridorexant in people with Healthy Volunteer, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Endpoints1 (time frame: Day1-Day11). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.