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Treatment B (5 × 25 mg daridorexant) for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Idorsia Pharmaceuticals Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up blood samples for pk analysis will be taken at several timepoints from treatment administration on day 1 to day 3 of study periods 1 and 2 (total duration: up to 4 days)

Awards & highlights

Study Summary

This trial tests if two different doses of a drug are equally effective in healthy Japanese men & women.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood samples for pk analysis will be taken at several timepoints from treatment administration on day 1 to day 3 of study periods 1 and 2 (total duration: up to 4 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood samples for pk analysis will be taken at several timepoints from treatment administration on day 1 to day 3 of study periods 1 and 2 (total duration: up to 4 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples for pk analysis will be taken at several timepoints from treatment administration on day 1 to day 3 of study periods 1 and 2 (total duration: up to 4 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC0-t

Cmax

Other outcome measures

AUC0-inf

T1/2

Tmax

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment B (5 × 25 mg daridorexant)Experimental Treatment1 Intervention

Participants will receive a single oral dose of 2 × 25 mg daridorexant.

Group II: Treatment A (5 × 10 mg daridorexant)Experimental Treatment1 Intervention

Participants will receive a single oral dose of 5 × 10 mg daridorexant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daridorexant 25 mg

2023

Completed Phase 3

~1810

Daridorexant 10 mg

2023

Completed Phase 3

~850

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Idorsia Pharmaceuticals Ltd.Lead Sponsor

118 Previous Clinical Trials

32,419 Total Patients Enrolled

Clinical Trials Study DirectorStudy DirectorIdosia Pharmaceuticals Ltd

1 Previous Clinical Trials

24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must a participant satisfy to qualify for this experiment?

"Applicants to this experiment should be adults between 18 and 65 with general physical health. Approximately 38 participants are still being sought after."

Answered by AI

How many participants are recruited for this experiment?

"Affirmative. According to the clinicaltrials.gov, this research study is actively seeking patients and has been since June 23rd 2023. As of July 13th 2023, 38 participants are needed from one medical centre for full participation in the trial."

Answered by AI

Does this trial accommodate individuals of advanced age?

"To qualify for this medical trial, applicants must be within the range of 18-65 years old. There are 55 separate trials specifically targeting minors and 370 clinical studies that cater to seniors."

Answered by AI

Are investigators still accepting enrollees for this experiment?

"That is accurate. The clinical trial's online listing on clinicaltrials.gov affirms that the research project, which was initially posted on June 23rd 2023, is actively seeking out participants. 38 subjects need to be recruited from 1 medical site."

Answered by AI

Has the Food and Drug Administration given its stamp of approval to 5 × 10 mg daridorexant (Treatment A)?

"Due to the Phase 1 nature of this trial, Treatment A (5 × 10 mg daridorexant) has been assigned a score of 1 on our safety scale from Power; since there is limited data in regards to its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants

2023. "A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05877222.