InsomniaPhase 1NCT01055834

A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)

A Phase 1 study testing Eszopiclone 3 mg and Eszopiclone 1 mg in people with Insomnia, run by Eisai Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters. Read more about this study

Who is it for?: Ages 20 to 54 years, men onlyHealthy volunteers can take part
Conditions the study is for: Insomnia
What is being tested?: Eszopiclone 3 mg and Eszopiclone 1 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteJapan
Study dates: Jan 2010to Feb 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 54 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Participants who are given a full explanation about the objective and details of this study before starting screening and give written consent based on their free will
Japanese healthy male adult volunteers
Participants who are between 20 and 54 years of age at the time of obtaining written consent
Body Mass Index (BMI) is between 18.5 kg/m2 and 25.0 kg/m2 at the time of screening

Who cannot join

Participants with a present illness or history of allergy to drug or food, or seasonal allergy
Participants who have a known history of any gastrointestinal surgery (e.g., hepatectomy, nephrotomy, etc.) that may affect pharmacokinetic evaluation
Participants who are found to have clinically abnormal findings in medical history, symptoms and clinical findings, vital signs, electrocardiograms, or laboratory parameters of which require medical treatment(s), or impaired organ functions
Participants who have a known or suspected history of alcohol or drug abuse, or those who have a positive urine drug screening
Participants who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or those who are human immunodeficiency virus (HIV)-positive, or those who are positive for syphilis screen
Participants who underwent blood transfusion within 12 weeks prior to, those whose 400 mL or more of whole blood was collected within 12 weeks prior to, or those whose 200 mL or more of whole blood was collected within 4 week prior to study drug administration

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Sumida City, Tokyo

Other trials in Japan

About this study

Official title: A Bioequivalence Study of Different Formulations of SEP-190 and Food Effect Study in Japanese Healthy Adult Males

The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.

Conditions: Insomnia
Being tested: Eszopiclone 3 mg, Eszopiclone 1 mg
Keywords: Insomnia, primary insomnia, insomnia associated with psychiatric or physical disorder(s)
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Eszopiclone 3 mgDrug
Group A Period I, Group B Period II:
Eszopiclone 3 mg tablet taken orally (po) with water as a single administration in the morning after fasting >=10 hours.
Except for the water taken with the drug, participants were not allowed any food/ drink from 10 hours before until 4 hours after administration of drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of drug.
Group B Period III:
Eszopiclone 3 mg tablet taken po with water as a single administration in the morning 30 minutes after the start of breakfast.
Except for the food/ drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink from 10 hours before until 4 hours after administration of the drug. Except for the food/ drink at breakfast \& the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration.
Eszopiclone 1 mgDrug
Group A Period II, Group B Period I:
Eszopiclone three 1 mg tablets (total: 3 mg) taken orally with water as a single administration in the morning after fasting 10 or more hours.
Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug.

Study groups in NCT01055834
Study group	Role	What they receive
Eszopiclone 3 mg tablet	Experimental	Not described Receives: Drug: Eszopiclone 3 mg
Eszopiclone 1 mg tablet	Experimental	Not described Receives: Drug: Eszopiclone 1 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)
Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to confirm bioequivalence. Cmax was measured in nanograms per milliliter (ng/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Measured: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to confirm bioequivalence. AUC was measured in nanogram hours per milliliter (ng*h/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Measured: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)
Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to investigate the effect of food. Cmax was measured in nanograms per milliliter (ng/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Measured: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to investigate the effect of food. AUC was measured in nanogram hours per milliliter (ng*h/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Measured: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Feb 2010

First posted26 Jan 2010 (estimated)
Study startJan 2010
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InsomniaStudies of the same condition, open and under way.
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: Crossover
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01055834
Sponsor's protocol ID: 190-102
Status last verified: Jan 2013
First submitted: 25 Jan 2010
Last updated: 12 Feb 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
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RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Bioequivalence Study of Different Formulations of SEP-190 and Food Effect Study in Japanese Healthy Adult Males
ClinicalTrials.gov ID: NCT01055834
Acronym / sponsor ID: 190-102
Conditions: Insomnia
Keywords: Insomnia, primary insomnia, insomnia associated with psychiatric or physical disorder(s)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Eisai Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 26 Jan 2010 (estimated)
Results: Posted 12 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Eszopiclone 3 mg tablet	Experimental	Drug: Eszopiclone 3 mg
Eszopiclone 1 mg tablet	Experimental	Drug: Eszopiclone 1 mg

Who may qualify

Ages: 20 to 54 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Participants who are given a full explanation about the objective and details of this study before starting screening and give written consent based on their free will
Japanese healthy male adult volunteers
Participants who are between 20 and 54 years of age at the time of obtaining written consent
Body Mass Index (BMI) is between 18.5 kg/m2 and 25.0 kg/m2 at the time of screening

Key exclusion criteria (6 listed)

Participants with a present illness or history of allergy to drug or food, or seasonal allergy
Participants who have a known history of any gastrointestinal surgery (e.g., hepatectomy, nephrotomy, etc.) that may affect pharmacokinetic evaluation
Participants who are found to have clinically abnormal findings in medical history, symptoms and clinical findings, vital signs, electrocardiograms, or laboratory parameters of which require medical treatment(s), or impaired organ functions
Participants who have a known or suspected history of alcohol or drug abuse, or those who have a positive urine drug screening
Participants who are positive for hepatitis B surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or those who are human immunodeficiency virus (HIV)-positive, or those who are positive for syphilis screen

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
Eszopiclone 3 mgGroup A Period I, Group B Period II: Eszopiclone 3 mg tablet taken orally (po) with water as a single administration in the morning after fasting >=10 hours. Except for the water taken with the drug, participants were not allowed any food/ drink from 10 hours before until 4 hours after administration of drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of drug. Group B Period III: Eszopiclone 3 mg tablet taken po with water as a single administration in the morning 30 minutes after the start of breakfast. Except for the food/ drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink from 10 hours before until 4 hours after administration of the drug. Except for the food/ drink at breakfast \& the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration.	Drug	Eszopiclone 3 mg tablet
Eszopiclone 1 mgGroup A Period II, Group B Period I: Eszopiclone three 1 mg tablets (total: 3 mg) taken orally with water as a single administration in the morning after fasting 10 or more hours. Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug.	Drug	Eszopiclone 1 mg tablet

Primary outcome

Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)
Time frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to confirm bioequivalence. Cmax was measured in nanograms per milliliter (ng/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
Time frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to confirm bioequivalence. AUC was measured in nanogram hours per milliliter (ng*h/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)
Time frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to investigate the effect of food. Cmax was measured in nanograms per milliliter (ng/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).
Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
Time frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to investigate the effect of food. AUC was measured in nanogram hours per milliliter (ng*h/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).

Results and safety

Results posted to the registry on 12 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs	21	20
Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab	21	21

Primary outcome: Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)

Time frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Eszopiclone One 3 mg Tablet n = 41	Eszopiclone Three 1 mg Tablets n = 41
Value	40.80 (12.39)	40.21 (11.72)

Population analysed: Pharmacokinetic analysis set (bioequivalence set): All participants who completed the study and had their samples analyzed, except for one participant in Group A who discontinued the study in Period 1.

Primary outcome: Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])

Time frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Eszopiclone One 3 mg Tablet n = 41	Eszopiclone Three 1 mg Tablets n = 41
Value	212.59 (34.18)	210.03 (31.77)

Primary outcome: Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)

Time frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Eszopiclone One 3 mg Tablet n = 14
Fasted Cmax	37.59 (8.70)
Fed Cmax	26.56 (6.75)

Population analysed: Pharmacokinetic analysis set (food effect): 14 participants who completed both Period II and Period III, who had been assigned to move on to Period III when assigned to treatment groups.

Primary outcome: Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])

Time frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Eszopiclone One 3 mg Tablet n = 14
Fasted AUC [0-24]	199.17 (38.00)
Fed AUC [0-24]	194.53 (29.58)

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Eszopiclone One 3 mg Tablet	0 of 42 (0%)	2 of 42 (4.8%)	Not reported
Eszopiclone Three 1 mg Tablets	0 of 41 (0%)	4 of 41 (9.8%)	Not reported
Eszopiclone One 3 mg Tablet (Fed)	0 of 14 (0%)	0 of 14 (0%)	Not reported
Eszopiclone One 3 mg Tablet (Fasted)	0 of 14 (0%)	1 of 14 (7.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Insomnia

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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.

Kenya Nakai study director

Japan Clinical Pharmacology, Eisai Co., Ltd.

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 Eszopiclone 3 mg and Eszopiclone 1 mg in people with Insomnia, run by Eisai Co., Ltd. at 1 site in Japan.

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 4 inclusion and 6 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 12 Feb 2013. 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 Japan. 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?

Yes. Results are posted in the registry (first posted 12 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Parameter (Bioequivalence): Maximal Drug Concentration (Cmax) (time frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01055834.

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 12 Feb 2013.