Trial Outcomes & Findings for A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102) (NCT NCT01055834)
NCT ID: NCT01055834
Last Updated: 2013-02-12
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose
Results posted on
2013-02-12
Participant Flow
Participant milestones
| Measure |
Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs
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.
|
Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab
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.
|
|---|---|---|
|
Treatment Period I
STARTED
|
21
|
21
|
|
Treatment Period I
COMPLETED
|
20
|
21
|
|
Treatment Period I
NOT COMPLETED
|
1
|
0
|
|
Treatment Period II
STARTED
|
20
|
21
|
|
Treatment Period II
COMPLETED
|
20
|
21
|
|
Treatment Period II
NOT COMPLETED
|
0
|
0
|
|
Treatment Period III
STARTED
|
0
|
14
|
|
Treatment Period III
COMPLETED
|
0
|
14
|
|
Treatment Period III
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs
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.
|
Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab
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.
|
|---|---|---|
|
Treatment Period I
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
Baseline characteristics by cohort
| Measure |
Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs
n=20 Participants
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.
|
Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab
n=21 Participants
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
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
29.3 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
33.0 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
31.2 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dosePopulation: 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.
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).
Outcome measures
| Measure |
Eszopiclone One 3 mg Tablet
n=41 Participants
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.
|
Eszopiclone Three 1 mg Tablets
n=41 Participants
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.
|
|---|---|---|
|
Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)
|
40.80 ng/mL
Standard Deviation 12.39
|
40.21 ng/mL
Standard Deviation 11.72
|
PRIMARY outcome
Timeframe: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dosePopulation: 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.
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).
Outcome measures
| Measure |
Eszopiclone One 3 mg Tablet
n=41 Participants
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.
|
Eszopiclone Three 1 mg Tablets
n=41 Participants
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.
|
|---|---|---|
|
Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
|
212.59 ng*h/mL
Standard Deviation 34.18
|
210.03 ng*h/mL
Standard Deviation 31.77
|
PRIMARY outcome
Timeframe: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dosePopulation: 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.
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).
Outcome measures
| Measure |
Eszopiclone One 3 mg Tablet
n=14 Participants
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.
|
Eszopiclone Three 1 mg Tablets
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.
|
|---|---|---|
|
Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)
Fasted Cmax
|
37.59 ng/mL
Standard Deviation 8.70
|
—
|
|
Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)
Fed Cmax
|
26.56 ng/mL
Standard Deviation 6.75
|
—
|
PRIMARY outcome
Timeframe: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dosePopulation: 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.
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).
Outcome measures
| Measure |
Eszopiclone One 3 mg Tablet
n=14 Participants
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.
|
Eszopiclone Three 1 mg Tablets
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.
|
|---|---|---|
|
Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
Fasted AUC [0-24]
|
199.17 ng*hr/mL
Standard Deviation 38.00
|
—
|
|
Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])
Fed AUC [0-24]
|
194.53 ng*hr/mL
Standard Deviation 29.58
|
—
|
Adverse Events
Eszopiclone One 3 mg Tablet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Eszopiclone Three 1 mg Tablets
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Eszopiclone One 3 mg Tablet (Fed)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Eszopiclone One 3 mg Tablet (Fasted)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eszopiclone One 3 mg Tablet
n=42 participants at risk
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
n=41 participants at risk
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).
|
Eszopiclone One 3 mg Tablet (Fed)
n=14 participants at risk
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.
|
Eszopiclone One 3 mg Tablet (Fasted)
n=14 participants at risk
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.
|
|---|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
2.4%
1/42
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.
|
7.3%
3/41
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.
|
0.00%
0/14
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.
|
7.1%
1/14
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.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.4%
1/42
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.
|
0.00%
0/41
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.
|
0.00%
0/14
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.
|
0.00%
0/14
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.
|
|
General disorders
Pyrexia
|
0.00%
0/42
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.
|
2.4%
1/41
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.
|
0.00%
0/14
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.
|
0.00%
0/14
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place