Trial Outcomes & Findings for Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea (NCT NCT03471871)
NCT ID: NCT03471871
Last Updated: 2020-02-17
Results Overview
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using polysomnography (PSG).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
146 participants
Primary outcome timeframe
Day 1
Results posted on
2020-02-17
Participant Flow
Participants took part in the study at 8 investigative sites in the United States from February 21, 2018 to August 3, 2018.
In healthy volunteer (HV) cohort, 39 participants were screened and enrolled, of which 22 were screen failures, 17 were randomized to receive treatment. In obstructive sleep apnea (OSA) cohort, 107 participants were screened and enrolled, of which 68 were screen failures, 39 were randomized to receive treatment. Total participants enrolled=146
Participant milestones
| Measure |
HV Cohort,Sequence A:Placebo,Lemborexant 10mg,Lemborexant 25mg
Eligible healthy adult and elderly participants received lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 1, followed by lemborexant 10 mg (milligram) (1 lemborexant 10 mg tablet and 2 matching placebo tablets \[to maintain blind\]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 2, and then lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each treatment period.
|
HV Cohort,Sequence B:Lemborexant 10mg,Lemborexant 25mg,Placebo
Eligible healthy adult and elderly participants received lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets \[to maintain blind\]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 1, followed by lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 2, and then lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each treatment period.
|
HV Cohort,Sequence C:Lemborexant 25mg,Placebo,Lemborexant 10mg
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 1, followed by lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 2, and then lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets \[to maintain blind\]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each treatment period.
|
OSA Cohort, Sequence D: Placebo, Lemborexant 10mg
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between each treatment period.
|
OSA Cohort, Sequence E: Lemborexant 10mg, Placebo
Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once in the evening of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo, tablet, orally, once, in the evening of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between each treatment period.
|
|---|---|---|---|---|---|
|
Treatment Period 1(HV:1 Day, OSA:8 Days)
STARTED
|
6
|
5
|
6
|
19
|
20
|
|
Treatment Period 1(HV:1 Day, OSA:8 Days)
Treated
|
6
|
5
|
6
|
18
|
20
|
|
Treatment Period 1(HV:1 Day, OSA:8 Days)
COMPLETED
|
6
|
5
|
5
|
18
|
19
|
|
Treatment Period 1(HV:1 Day, OSA:8 Days)
NOT COMPLETED
|
0
|
0
|
1
|
1
|
1
|
|
Washout Period 1 (14 Days)
STARTED
|
6
|
5
|
5
|
18
|
19
|
|
Washout Period 1 (14 Days)
COMPLETED
|
6
|
5
|
5
|
18
|
19
|
|
Washout Period 1 (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2(HV:1 Day, OSA:8 Days)
STARTED
|
6
|
5
|
5
|
18
|
19
|
|
Treatment Period 2(HV:1 Day, OSA:8 Days)
COMPLETED
|
6
|
5
|
5
|
18
|
18
|
|
Treatment Period 2(HV:1 Day, OSA:8 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
Washout Period 2 (14 Days)
STARTED
|
6
|
5
|
5
|
0
|
0
|
|
Washout Period 2 (14 Days)
COMPLETED
|
6
|
5
|
5
|
0
|
0
|
|
Washout Period 2 (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3: ( HV:1 Day)
STARTED
|
6
|
5
|
5
|
0
|
0
|
|
Treatment Period 3: ( HV:1 Day)
COMPLETED
|
6
|
5
|
5
|
0
|
0
|
|
Treatment Period 3: ( HV:1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Follow Up (14 Days for Both HV and OSA)
STARTED
|
6
|
5
|
5
|
18
|
18
|
|
Follow Up (14 Days for Both HV and OSA)
COMPLETED
|
6
|
5
|
5
|
17
|
17
|
|
Follow Up (14 Days for Both HV and OSA)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
HV Cohort,Sequence A:Placebo,Lemborexant 10mg,Lemborexant 25mg
Eligible healthy adult and elderly participants received lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 1, followed by lemborexant 10 mg (milligram) (1 lemborexant 10 mg tablet and 2 matching placebo tablets \[to maintain blind\]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 2, and then lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each treatment period.
|
HV Cohort,Sequence B:Lemborexant 10mg,Lemborexant 25mg,Placebo
Eligible healthy adult and elderly participants received lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets \[to maintain blind\]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 1, followed by lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 2, and then lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each treatment period.
|
HV Cohort,Sequence C:Lemborexant 25mg,Placebo,Lemborexant 10mg
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 1, followed by lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 2, and then lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets \[to maintain blind\]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 of Treatment Period 3. A washout period of 14 days was maintained between each treatment period.
|
OSA Cohort, Sequence D: Placebo, Lemborexant 10mg
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between each treatment period.
|
OSA Cohort, Sequence E: Lemborexant 10mg, Placebo
Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once in the evening of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo, tablet, orally, once, in the evening of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between each treatment period.
|
|---|---|---|---|---|---|
|
Treatment Period 1(HV:1 Day, OSA:8 Days)
Work Demand: Return to work
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 1(HV:1 Day, OSA:8 Days)
Protocol deviation
|
0
|
0
|
0
|
1
|
1
|
|
Treatment Period 2(HV:1 Day, OSA:8 Days)
Other
|
0
|
0
|
0
|
0
|
1
|
|
Follow Up (14 Days for Both HV and OSA)
Protocol Deviation
|
0
|
0
|
0
|
0
|
1
|
|
Follow Up (14 Days for Both HV and OSA)
Did Return to Clinic
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
HV Cohort
n=17 Participants
Eligible healthy adult and elderly participants received lemborexant-matched placebo (3 placebo tablets), lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets \[to maintain blind\]) or lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3. A washout period of 14 days was maintained between each treatment period.
|
OSA Cohort
n=39 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo or one lemborexant 10 mg, tablets, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2. A washout period of 14 days was maintained between each treatment period.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacodynamic (PD) analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter.
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using polysomnography (PSG).
Outcome measures
| Measure |
OSA Cohort: Placebo
n=16 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
OSA Cohort: Lemborexant 10 mg
n=16 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
HV Cohort: Lemborexant 25 mg
n=16 Participants
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
|
|---|---|---|---|
|
HV Cohort: Peripheral Oxygen Saturation (SpO2) During Total Sleep Time (TST) on Day 1 of Treatment
|
95.34 percentage of oxygen saturation
Standard Deviation 0.900
|
95.00 percentage of oxygen saturation
Standard Deviation 1.283
|
95.07 percentage of oxygen saturation
Standard Deviation 1.311
|
PRIMARY outcome
Timeframe: Day 8Population: PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=35 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
OSA Cohort: Lemborexant 10 mg
n=37 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
HV Cohort: Lemborexant 25 mg
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
|
|---|---|---|---|
|
OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment
|
10.03 events (apnea plus hyponea) per hour
Standard Deviation 6.799
|
9.99 events (apnea plus hyponea) per hour
Standard Deviation 5.878
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter.
The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=16 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
OSA Cohort: Lemborexant 10 mg
n=16 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
HV Cohort: Lemborexant 25 mg
n=16 Participants
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
|
|---|---|---|---|
|
HV Cohort: AHI on Day 1 of Treatment
|
4.69 events (apnea plus hyponea) per hour
Standard Deviation 8.183
|
5.29 events (apnea plus hyponea) per hour
Standard Deviation 10.484
|
3.55 events (apnea plus hyponea) per hour
Standard Deviation 6.585
|
SECONDARY outcome
Timeframe: Day 1Population: PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=37 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
OSA Cohort: Lemborexant 10 mg
n=36 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
HV Cohort: Lemborexant 25 mg
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
|
|---|---|---|---|
|
OSA Cohort: AHI on Day 1 of Treatment
|
10.24 events (apnea plus hyponea) per hour
Standard Deviation 7.094
|
10.29 events (apnea plus hyponea) per hour
Standard Deviation 6.681
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter.
TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=16 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
OSA Cohort: Lemborexant 10 mg
n=16 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
HV Cohort: Lemborexant 25 mg
n=16 Participants
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
|
|---|---|---|---|
|
HV Cohort: Percentage of TST During Which SpO2 Was Less Than (<) 90 Percent (%), 85 % and 80 % on Day 1 of Treatment
SpO2 <90%
|
0.037 percentage of TST
Standard Deviation 0.0968
|
0.224 percentage of TST
Standard Deviation 0.3755
|
0.287 percentage of TST
Standard Deviation 0.5555
|
|
HV Cohort: Percentage of TST During Which SpO2 Was Less Than (<) 90 Percent (%), 85 % and 80 % on Day 1 of Treatment
SpO2 <85%
|
0 percentage of TST
Standard Deviation 0
|
0.004 percentage of TST
Standard Deviation 0.0109
|
0.047 percentage of TST
Standard Deviation 0.1516
|
|
HV Cohort: Percentage of TST During Which SpO2 Was Less Than (<) 90 Percent (%), 85 % and 80 % on Day 1 of Treatment
SpO2 <80%
|
0 percentage of TST
Standard Deviation 0
|
0.001 percentage of TST
Standard Deviation 0.0034
|
0.003 percentage of TST
Standard Deviation 0.0077
|
SECONDARY outcome
Timeframe: Day 1Population: PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter.
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=16 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
OSA Cohort: Lemborexant 10 mg
n=16 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
HV Cohort: Lemborexant 25 mg
n=16 Participants
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
|
|---|---|---|---|
|
HV Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 of Treatment
|
31.3 percentage of participant
|
31.3 percentage of participant
|
37.5 percentage of participant
|
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, 'number analyzed' signifies participants who were evaluable for analysis at the specified timepoints.
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=37 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
OSA Cohort: Lemborexant 10 mg
n=37 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
HV Cohort: Lemborexant 25 mg
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
|
|---|---|---|---|
|
OSA Cohort: SpO2 During TST on Day 1 and Day 8 of Treatment
Day 1
|
94.53 percentage of oxygen saturation
Standard Deviation 1.620
|
94.54 percentage of oxygen saturation
Standard Deviation 1.470
|
—
|
|
OSA Cohort: SpO2 During TST on Day 1 and Day 8 of Treatment
Day 8
|
94.46 percentage of oxygen saturation
Standard Deviation 1.316
|
94.65 percentage of oxygen saturation
Standard Deviation 1.539
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, 'number analyzed' signifies participants who were evaluable for analysis at the specified timepoints.
TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=37 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
OSA Cohort: Lemborexant 10 mg
n=37 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
HV Cohort: Lemborexant 25 mg
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
|
|---|---|---|---|
|
OSA Cohort: Percentage of TST During Which the SpO2 is <90%, 85% and 80 % on Day 1 and Day 8 of Treatment
Day 8: SpO2 <90%
|
1.011 percentage of TST
Standard Deviation 1.4210
|
1.102 percentage of TST
Standard Deviation 1.5469
|
—
|
|
OSA Cohort: Percentage of TST During Which the SpO2 is <90%, 85% and 80 % on Day 1 and Day 8 of Treatment
Day 1: SpO2 <90%
|
1.044 percentage of TST
Standard Deviation 1.8851
|
1.362 percentage of TST
Standard Deviation 2.6170
|
—
|
|
OSA Cohort: Percentage of TST During Which the SpO2 is <90%, 85% and 80 % on Day 1 and Day 8 of Treatment
Day 1: SpO2 <85%
|
0.104 percentage of TST
Standard Deviation 0.3043
|
0.170 percentage of TST
Standard Deviation 0.5132
|
—
|
|
OSA Cohort: Percentage of TST During Which the SpO2 is <90%, 85% and 80 % on Day 1 and Day 8 of Treatment
Day 1: SpO2 <80%
|
0.012 percentage of TST
Standard Deviation 0.0483
|
0.014 percentage of TST
Standard Deviation 0.0433
|
—
|
|
OSA Cohort: Percentage of TST During Which the SpO2 is <90%, 85% and 80 % on Day 1 and Day 8 of Treatment
Day 8: SpO2 <85%
|
0.109 percentage of TST
Standard Deviation 0.2974
|
0.162 percentage of TST
Standard Deviation 0.4350
|
—
|
|
OSA Cohort: Percentage of TST During Which the SpO2 is <90%, 85% and 80 % on Day 1 and Day 8 of Treatment
Day 8: SpO2 <80%
|
0.009 percentage of TST
Standard Deviation 0.0366
|
0.015 percentage of TST
Standard Deviation 0.0603
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 8Population: PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter.
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.
Outcome measures
| Measure |
OSA Cohort: Placebo
n=37 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
OSA Cohort: Lemborexant 10 mg
n=37 Participants
Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
HV Cohort: Lemborexant 25 mg
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
|
|---|---|---|---|
|
OSA Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 and Day 8 of Treatment
Day 1: SpO2 <90%
|
67.6 percentage of participant
|
75.7 percentage of participant
|
—
|
|
OSA Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 and Day 8 of Treatment
Day 8: SpO2 <90%
|
75.7 percentage of participant
|
83.8 percentage of participant
|
—
|
Adverse Events
HV Cohort: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
HV Cohort: Lemborexant 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
HV Cohort: Lemborexant 25 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
OSA Cohort: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
OSA Cohort: Lemborexant 10 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HV Cohort: Placebo
n=16 participants at risk
Eligible healthy adult and elderly participants received lemborexant-matched placebo (3 placebo tablets), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
|
HV Cohort: Lemborexant 10 mg
n=16 participants at risk
Eligible healthy adult and elderly participants received lemborexant 10 mg (1 lemborexant 10 mg tablet and 2 matching placebo tablets \[to maintain blind\]), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
|
HV Cohort: Lemborexant 25 mg
n=17 participants at risk
Eligible healthy adult and elderly participants received lemborexant 25 mg (2 lemborexant 10 mg tablets and 1 lemborexant 5 mg tablet), orally, once, in the evening (within 5 minutes of lights off) of Day 1 in the respective Treatment Period 1, 2 or 3.
|
OSA Cohort: Placebo
n=38 participants at risk
Eligible adult and elderly participants with mild OSA received one lemborexant-matched placebo, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
OSA Cohort: Lemborexant 10 mg
n=38 participants at risk
Eligible adult and elderly participants with mild OSA received one lemborexant 10 mg, tablet, orally, once, in the evening (within 5 minutes of lights off) of Day 1 through Day 8 in the respective Treatment Period 1 or 2.
|
|---|---|---|---|---|---|
|
Eye disorders
Photopsia
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
5.9%
1/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
5.9%
1/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
5.9%
1/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
5.9%
1/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
5.9%
1/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
2.6%
1/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
6.2%
1/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
5.9%
1/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
5.3%
2/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.2%
1/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
2.6%
1/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
2.6%
1/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
General disorders
Asthenia
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
2.6%
1/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
2.6%
1/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
2.6%
1/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
2.6%
1/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
2.6%
1/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
2.6%
1/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/16 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/17 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
2.6%
1/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
0.00%
0/38 • Baseline up to end of follow up visit (up to 67 days)
Safety analysis set included group of participants who received study drug and had at least 1 postdose safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place