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

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ClinicalTrials.gov Identifier: NCT01055834
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : February 12, 2013
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Insomnia
Interventions Drug: Eszopiclone 3 mg
Drug: Eszopiclone 1 mg
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab
Hide Arm/Group Description Participants received a single dose of Eszopiclone one 3 mg tablet administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in Period II. At least a 5 day period passed before post treatment examinations.

Participants received a single dose of Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone one 3 mg tablet with water in the morning after fasting for 10 or more hours in Period II.

After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations.

Period Title: Treatment Period I
Started 21 21
Completed 20 21
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Treatment Period II
Started 20 21
Completed 20 21
Not Completed 0 0
Period Title: Treatment Period III
Started 0 [1] 14 [2]
Completed 0 14
Not Completed 0 0
[1]
Participants from Group A did not continue into Period III.
[2]
14 of 21 participants in Group B who were treated in Period II participated in Period III.
Arm/Group Title Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab Total
Hide Arm/Group Description Participants received Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II. At least a 5 day period passed before post treatment examinations.

Participants received Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone one 3 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II.

After Period II there was at least a 5 day washout period. Certain participants from Group B only proceeded to Period III where they received Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast for 3 days. At least a 5 day period passed before post treatment examinations.

Total of all reporting groups
Overall Number of Baseline Participants 20 21 41
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 41 participants
29.3  (6.0) 33.0  (9.4) 31.2  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
21
 100.0%
41
 100.0%
1.Primary Outcome
Title Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)
Hide Description 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).
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Eszopiclone One 3 mg Tablet Eszopiclone Three 1 mg Tablets
Hide Arm/Group Description:

Group A Period I, Group B Period II:

Eszopiclone one 3 mg tablet administered orally as a single administration with water in the morning after fasting for 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.

Group A Period II, Group B Period I:

Eszopiclone three 1 mg tablets administered orally as a single administration with water in the morning after fasting for 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.

Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: ng/mL
40.80  (12.39) 40.21  (11.72)
2.Primary Outcome
Title Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
Hide Description 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).
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Eszopiclone One 3 mg Tablet Eszopiclone Three 1 mg Tablets
Hide Arm/Group Description:

Group A Period I, Group B Period II:

Eszopiclone one 3 mg tablet administered orally as a single administration with water in the morning after fasting for 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.

Group A Period II, Group B Period I:

Eszopiclone three 1 mg tablets administered orally as a single administration with water in the morning after fasting for 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.

Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
212.59  (34.18) 210.03  (31.77)
3.Primary Outcome
Title Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)
Hide Description 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).
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Eszopiclone One 3 mg Tablet
Hide Arm/Group Description:

Group B Period III:

After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations.

Except for the food and drink at breakfast and 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 food and drink at breakfast and 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.

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
Fasted Cmax 37.59  (8.70)
Fed Cmax 26.56  (6.75)
4.Primary Outcome
Title Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
Hide Description 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).
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Eszopiclone One 3 mg Tablet
Hide Arm/Group Description:

Group B Period III:

After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations.

Except for the food and drink at breakfast and 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 food and drink at breakfast and 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.

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Fasted AUC [0-24] 199.17  (38.00)
Fed AUC [0-24] 194.53  (29.58)
Time Frame [Not Specified]
Adverse Event Reporting Description

Safety Analysis Set (bioequivalence): population treated in Period I except for those subjects with no available safety data.

Safety analysis set (food effect): is defined as the "safety analysis set (bioequivalence)" except for those subjects with no evaluable safety data in Period III.

 
Arm/Group Title Eszopiclone One 3 mg Tablet Eszopiclone Three 1 mg Tablets Eszopiclone One 3 mg Tablet (Fed) Eszopiclone One 3 mg Tablet (Fasted)
Hide Arm/Group Description Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II). Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II). After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fed conditions. After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fasted conditions.
All-Cause Mortality
Eszopiclone One 3 mg Tablet Eszopiclone Three 1 mg Tablets Eszopiclone One 3 mg Tablet (Fed) Eszopiclone One 3 mg Tablet (Fasted)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eszopiclone One 3 mg Tablet Eszopiclone Three 1 mg Tablets Eszopiclone One 3 mg Tablet (Fed) Eszopiclone One 3 mg Tablet (Fasted)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/41 (0.00%)   0/14 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Eszopiclone One 3 mg Tablet Eszopiclone Three 1 mg Tablets Eszopiclone One 3 mg Tablet (Fed) Eszopiclone One 3 mg Tablet (Fasted)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/42 (4.76%)   4/41 (9.76%)   0/14 (0.00%)   1/14 (7.14%) 
General disorders         
Pyrexia  0/42 (0.00%)  1/41 (2.44%)  0/14 (0.00%)  0/14 (0.00%) 
Nervous system disorders         
Dysgeusia  1/42 (2.38%)  3/41 (7.32%)  0/14 (0.00%)  1/14 (7.14%) 
Skin and subcutaneous tissue disorders         
Urticaria  1/42 (2.38%)  0/41 (0.00%)  0/14 (0.00%)  0/14 (0.00%) 
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kenya Nakai, Study Director
Organization: Eisai Co., Ltd.
Phone: +81-3-3817-3865
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01055834     History of Changes
Other Study ID Numbers: 190-102
First Submitted: January 25, 2010
First Posted: January 26, 2010
Results First Submitted: January 10, 2013
Results First Posted: February 12, 2013
Last Update Posted: February 12, 2013