Trial Outcomes & Findings for Study of Nalbuphine ER in Participants With Hepatic Impairment (NCT NCT04020016)
NCT ID: NCT04020016
Last Updated: 2026-03-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level
Results posted on
2026-03-19
Participant Flow
Participants were enrolled at 3 sites in the United States from 12 June 2019 to 05 February 2020.
A total of 66 participants were screened and 28 participants were enrolled. The study was planned to be conducted in 2 parts: Part 1 (Single Ascending Dose \[SAD\]) followed by Part 2 (Multiple Ascending Dose \[MAD\]). As per the judgement of the safety committee, Part 2 was not conducted based on protocol defined criteria. In Part 1, each cohort was dosed sequentially from lowest dose for mild and moderate impaired participants. Participants in Cohort 1 could also take part in Cohorts 2, 3, and 4.
Participant milestones
| Measure |
Cohort 1: NAL ER 27 mg
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 5: NAL ER 162 mg
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Cohort 1
STARTED
|
16
|
0
|
0
|
0
|
0
|
|
Cohort 1
COMPLETED
|
16
|
0
|
0
|
0
|
0
|
|
Cohort 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2
STARTED
|
0
|
15
|
0
|
0
|
0
|
|
Cohort 2
COMPLETED
|
0
|
15
|
0
|
0
|
0
|
|
Cohort 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 3
STARTED
|
0
|
0
|
15
|
0
|
0
|
|
Cohort 3
COMPLETED
|
0
|
0
|
15
|
0
|
0
|
|
Cohort 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Cohorts 4 and 5
STARTED
|
0
|
0
|
0
|
13
|
8
|
|
Cohorts 4 and 5
COMPLETED
|
0
|
0
|
0
|
13
|
8
|
|
Cohorts 4 and 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
Baseline characteristics by cohort
| Measure |
Part 1: All Participants
n=28 Participants
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose ranging from 27 mg up to 162 mg of NAL ER tablet under fasting conditions within Cohorts 1, 2, 3, 4, and 5. There was a washout period of at least 7 days between the drug administration between each dose level. Participants with no hepatic impairment (group 4) received a single dose of NAL ER of up to 162 mg under fasting conditions.
|
|---|---|
|
Age, Continuous
Cohort 1 (NAL ER 27 mg): Group 1
|
59.2 years
STANDARD_DEVIATION 5.6 • n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Age, Continuous
Cohort 1 (NAL ER 27 mg): Group 2
|
62.5 years
STANDARD_DEVIATION 5.1 • n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Age, Continuous
Cohort 1 (NAL ER 27 mg): Group 3
|
60.3 years
STANDARD_DEVIATION 9.0 • n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Age, Continuous
Cohort 2 (NAL ER 54 mg): Group 1
|
59.5 years
STANDARD_DEVIATION 4.9 • n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Age, Continuous
Cohort 2 (NAL ER 54 mg): Group 2
|
61.3 years
STANDARD_DEVIATION 5.6 • n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Age, Continuous
Cohort 3 (NAL ER 108 mg): Group 1
|
59.5 years
STANDARD_DEVIATION 4.9 • n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Age, Continuous
Cohort 3 (NAL ER 108 mg): Group 2
|
60.3 years
STANDARD_DEVIATION 6.1 • n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Age, Continuous
Cohort 4 (NAL ER 162 mg): Group 1
|
59.3 years
STANDARD_DEVIATION 5.3 • n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Age, Continuous
Cohort 4 (NAL ER 162 mg): Group 2
|
58.8 years
STANDARD_DEVIATION 5.2 • n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Age, Continuous
Cohort 5 (NAL ER 162 mg): Group 4
|
55.9 years
STANDARD_DEVIATION 5.7 • n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 1 (NAL ER 27 mg): Group 1 · Female
|
3 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 1 (NAL ER 27 mg): Group 1 · Male
|
3 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 1 (NAL ER 27 mg): Group 2 · Female
|
1 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 1 (NAL ER 27 mg): Group 2 · Male
|
5 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 1 (NAL ER 27 mg): Group 3 · Female
|
2 Participants
n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 1 (NAL ER 27 mg): Group 3 · Male
|
2 Participants
n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 2 (NAL ER 54 mg): Group 1 · Female
|
4 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 2 (NAL ER 54 mg): Group 1 · Male
|
4 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 2 (NAL ER 54 mg): Group 2 · Female
|
1 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 2 (NAL ER 54 mg): Group 2 · Male
|
6 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 3 (NAL ER 108 mg): Group 1 · Female
|
4 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 3 (NAL ER 108 mg): Group 1 · Male
|
4 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 3 (NAL ER 108 mg): Group 2 · Female
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 3 (NAL ER 108 mg): Group 2 · Male
|
7 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 4 (NAL ER 162 mg): Group 1 · Female
|
3 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 4 (NAL ER 162 mg): Group 1 · Male
|
4 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 4 (NAL ER 162 mg): Group 2 · Female
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 4 (NAL ER 162 mg): Group 2 · Male
|
6 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 5 (NAL ER 162 mg): Group 4 · Female
|
3 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Sex: Female, Male
Cohort 5 (NAL ER 162 mg): Group 4 · Male
|
5 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 1 · Hispanic or Latino
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 1 · Not Hispanic or Latino
|
6 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 1 · Unknown or Not Reported
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 2 · Hispanic or Latino
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 2 · Not Hispanic or Latino
|
6 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 2 · Unknown or Not Reported
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 3 · Hispanic or Latino
|
1 Participants
n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 3 · Not Hispanic or Latino
|
3 Participants
n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 3 · Unknown or Not Reported
|
0 Participants
n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 1 · Hispanic or Latino
|
1 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 1 · Not Hispanic or Latino
|
7 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 1 · Unknown or Not Reported
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 2 · Hispanic or Latino
|
1 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 2 · Not Hispanic or Latino
|
6 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 2 · Unknown or Not Reported
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 1 · Hispanic or Latino
|
4 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 1 · Not Hispanic or Latino
|
4 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 1 · Unknown or Not Reported
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 2 · Hispanic or Latino
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 2 · Not Hispanic or Latino
|
7 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 2 · Unknown or Not Reported
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 1 · Hispanic or Latino
|
3 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 1 · Not Hispanic or Latino
|
4 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 1 · Unknown or Not Reported
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 2 · Hispanic or Latino
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 2 · Not Hispanic or Latino
|
6 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 2 · Unknown or Not Reported
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 5 (NAL ER 162 mg): Group 4 · Hispanic or Latino
|
3 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 5 (NAL ER 162 mg): Group 4 · Not Hispanic or Latino
|
5 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Ethnicity (NIH/OMB)
Cohort 5 (NAL ER 162 mg): Group 4 · Unknown or Not Reported
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 1 · American Indian or Alaska Native
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 1 · Asian
|
1 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 1 · Black or African American
|
3 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 1 · White
|
2 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 1 · More than one race
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 1 · Unknown or Not Reported
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 2 · American Indian or Alaska Native
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 2 · Asian
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 2 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 2 · Black or African American
|
2 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 2 · White
|
4 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 2 · More than one race
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 2 · Unknown or Not Reported
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 3 · American Indian or Alaska Native
|
0 Participants
n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 3 · Asian
|
0 Participants
n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 3 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 3 · Black or African American
|
1 Participants
n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 3 · White
|
3 Participants
n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 3 · More than one race
|
0 Participants
n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 1 (NAL ER 27 mg): Group 3 · Unknown or Not Reported
|
0 Participants
n=4 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 1 · American Indian or Alaska Native
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 1 · Asian
|
1 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 1 · Black or African American
|
3 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 1 · White
|
4 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 1 · More than one race
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 1 · Unknown or Not Reported
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 2 · American Indian or Alaska Native
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 2 · Asian
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 2 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 2 · Black or African American
|
2 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 2 · White
|
5 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 2 · More than one race
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 2 (NAL ER 54 mg): Group 2 · Unknown or Not Reported
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 1 · American Indian or Alaska Native
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 1 · Asian
|
1 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 1 · Black or African American
|
3 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 1 · White
|
4 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 1 · More than one race
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 1 · Unknown or Not Reported
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 2 · American Indian or Alaska Native
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 2 · Asian
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 2 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 2 · Black or African American
|
1 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 2 · White
|
6 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 2 · More than one race
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 3 (NAL ER 108 mg): Group 2 · Unknown or Not Reported
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 1 · American Indian or Alaska Native
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 1 · Asian
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 1 · Black or African American
|
3 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 1 · White
|
4 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 1 · More than one race
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 1 · Unknown or Not Reported
|
0 Participants
n=7 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 2 · American Indian or Alaska Native
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 2 · Asian
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 2 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 2 · Black or African American
|
1 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 2 · White
|
5 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 2 · More than one race
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 4 (NAL ER 162 mg): Group 2 · Unknown or Not Reported
|
0 Participants
n=6 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 5 (NAL ER 162 mg): Group 4 · American Indian or Alaska Native
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 5 (NAL ER 162 mg): Group 4 · Asian
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 5 (NAL ER 162 mg): Group 4 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 5 (NAL ER 162 mg): Group 4 · Black or African American
|
2 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 5 (NAL ER 162 mg): Group 4 · White
|
6 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 5 (NAL ER 162 mg): Group 4 · More than one race
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
|
Race (NIH/OMB)
Cohort 5 (NAL ER 162 mg): Group 4 · Unknown or Not Reported
|
0 Participants
n=8 Participants • Participants in Cohort 1 in Part 1 of the study could also take part in Cohorts 2, 3, and 4.
|
PRIMARY outcome
Timeframe: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose levelPopulation: PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Number analyzed indicates number of participants who were evaluable for this outcome measure in a particular group.
Outcome measures
| Measure |
Cohort 5: NAL ER 162 mg
n=7 Participants
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
n=13 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 1: NAL ER 27 mg
n=16 Participants
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER
Mild Hepatic Impairment (Group 1)
|
—
|
13.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34.1
|
18.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34.9
|
3.30 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 41.8
|
7.67 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38.9
|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER
Moderate Hepatic Impairment (Group 2)
|
—
|
42.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.2
|
57.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 55.3
|
10.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 77.9
|
22.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 70.7
|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER
Severe Hepatic Impairment (Group 3)
|
—
|
—
|
—
|
27.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21.9
|
—
|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER
No Hepatic Impairment (Group 4)
|
25.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose levelPopulation: PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Number analyzed indicates number of participants who were evaluable for this outcome measure in a particular group.
Outcome measures
| Measure |
Cohort 5: NAL ER 162 mg
n=7 Participants
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
n=13 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 1: NAL ER 27 mg
n=16 Participants
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER
No Hepatic Impairment (Group 4)
|
5.000 hours (h)
Interval 2.983 to 9.0
|
—
|
—
|
—
|
—
|
|
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER
Mild Hepatic Impairment (Group 1)
|
—
|
5.000 hours (h)
Interval 1.5 to 12000.0
|
7.000 hours (h)
Interval 3.0 to 24.0
|
4.000 hours (h)
Interval 1.5 to 7.0
|
5.000 hours (h)
Interval 3.0 to 12.0
|
|
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER
Moderate Hepatic Impairment (Group 2)
|
—
|
9.000 hours (h)
Interval 3.0 to 12.0
|
7.000 hours (h)
Interval 3.0 to 12.0
|
3.000 hours (h)
Interval 3.0 to 9.0
|
5.000 hours (h)
Interval 3.0 to 12.067
|
|
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER
Severe Hepatic Impairment (Group 3)
|
—
|
—
|
—
|
6.000 hours (h)
Interval 3.0 to 9.0
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose levelPopulation: PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Overall number of participants analyzed is the number of participants with evaluable data for this outcome measure. Number analyzed indicates number of participants who were evaluable in a particular group.
Outcome measures
| Measure |
Cohort 5: NAL ER 162 mg
n=7 Participants
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
n=13 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
n=12 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 1: NAL ER 27 mg
n=14 Participants
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
n=12 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Part 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER
Mild Hepatic Impairment (Group 1)
|
—
|
8.80 h
Interval 4.95 to 12.05
|
9.55 h
Interval 7.14 to 11.49
|
7.83 h
Interval 6.46 to 12.27
|
11.92 h
Interval 7.94 to 14.08
|
|
Part 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER
Moderate Hepatic Impairment (Group 2)
|
—
|
7.81 h
Interval 5.92 to 11.63
|
8.25 h
Interval 5.48 to 13.69
|
7.97 h
Interval 5.15 to 11.77
|
7.56 h
Interval 5.82 to 10.36
|
|
Part 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER
Severe Hepatic Impairment (Group 3)
|
—
|
—
|
—
|
7.22 h
Interval 6.24 to 8.02
|
—
|
|
Part 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER
No Hepatic Impairment (Group 4)
|
10.00 h
Interval 6.84 to 14.09
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose levelPopulation: PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Overall number of participants analyzed is the number of participants with evaluable data for this outcome measure. Number analyzed indicates number of participants who were evaluable in a particular group.
Outcome measures
| Measure |
Cohort 5: NAL ER 162 mg
n=7 Participants
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
n=13 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
n=12 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 1: NAL ER 27 mg
n=14 Participants
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
n=12 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER
No Hepatic Impairment (Group 4)
|
374.83 hour-nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 67.77
|
—
|
—
|
—
|
—
|
|
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER
Mild Hepatic Impairment (Group 1)
|
—
|
300.09 hour-nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 32.28
|
356.12 hour-nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 34.16
|
68.15 hour-nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 36.63
|
141.56 hour-nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 42.73
|
|
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER
Moderate Hepatic Impairment (Group 2)
|
—
|
846.41 hour-nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 61.11
|
1074.11 hour-nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 62.42
|
194.12 hour-nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 79.81
|
396.03 hour-nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 74.70
|
|
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER
Severe Hepatic Impairment (Group 3)
|
—
|
—
|
—
|
491.26 hour-nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 20.21
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose levelPopulation: PK population consisted of all participants in the safety population for whom the PK profile could be adequately characterized. Number analyzed indicates number of participants who were evaluable for this outcome measure in a particular group.
Outcome measures
| Measure |
Cohort 5: NAL ER 162 mg
n=7 Participants
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
n=13 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 1: NAL ER 27 mg
n=16 Participants
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER
Mild Hepatic Impairment (Group 1)
|
—
|
250.97 h*ng/mL
Geometric Coefficient of Variation 39.10
|
357.32 h*ng/mL
Geometric Coefficient of Variation 31.57
|
40.82 h*ng/mL
Geometric Coefficient of Variation 62.46
|
114.96 h*ng/mL
Geometric Coefficient of Variation 45.27
|
|
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER
Moderate Hepatic Impairment (Group 2)
|
—
|
830.15 h*ng/mL
Geometric Coefficient of Variation 61.84
|
1050.63 h*ng/mL
Geometric Coefficient of Variation 63.55
|
180.63 h*ng/mL
Geometric Coefficient of Variation 83.26
|
377.56 h*ng/mL
Geometric Coefficient of Variation 76.03
|
|
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER
Severe Hepatic Impairment (Group 3)
|
—
|
—
|
—
|
482.29 h*ng/mL
Geometric Coefficient of Variation 20.14
|
—
|
|
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER
No Hepatic Impairment (Group 4)
|
355.42 h*ng/mL
Geometric Coefficient of Variation 70.21
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From signing the informed consent form up to Day 4Population: Safety analysis set (SAS) included all enrolled participants who had received at least 1 dose of study drug.
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE was defined as any AE that occurs after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.
Outcome measures
| Measure |
Cohort 5: NAL ER 162 mg
n=8 Participants
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
n=13 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 1: NAL ER 27 mg
n=16 Participants
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Part 1: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)
|
5 Participants
|
9 Participants
|
12 Participants
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From signing the informed consent form up to Day 4Population: SAS included all enrolled participants who had received at least 1 dose of study drug.
The clinical laboratory parameters included the clinical chemistry, hematology, coagulation, and urinalysis. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 5: NAL ER 162 mg
n=8 Participants
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
n=13 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 1: NAL ER 27 mg
n=16 Participants
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From signing the informed consent form up to Day 4Population: SAS included all enrolled participants who had received at least 1 dose of study drug.
Vital signs measurements included diastolic and systolic blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 5: NAL ER 162 mg
n=8 Participants
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
n=13 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 1: NAL ER 27 mg
n=16 Participants
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Findings in Vital Sign Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From signing the informed consent form up to Day 4Population: SAS included all enrolled participants who had received at least 1 dose of study drug.
Physical examination included examination of at least the following components: head, eyes, ears, nose, throat (HEENT), neck, lungs, abdomen, skin, cardiovascular and musculoskeletal evaluation, and general neurological examination. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 5: NAL ER 162 mg
n=8 Participants
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
n=13 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 1: NAL ER 27 mg
n=16 Participants
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Findings in Physical Examination Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From signing the informed consent form up to Day 4Population: SAS included all enrolled participants who had received at least 1 dose of study drug.
ECG data included the measurement of heart rate and aggregate PR interval, QRS duration, QT interval, QTcB interval, and QTcF interval.
Outcome measures
| Measure |
Cohort 5: NAL ER 162 mg
n=8 Participants
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
n=13 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 1: NAL ER 27 mg
n=16 Participants
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 1.5, 4, 5, and 8 hours post-dose in each dose levelPopulation: SAS included all enrolled participants who had received at least 1 dose of study drug.
Oxygen saturation was measured via pulse oximetry. Pulse oximetry measurements were to be collected within 10 min before or after the specified time point. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Cohort 5: NAL ER 162 mg
n=8 Participants
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
n=13 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 1: NAL ER 27 mg
n=16 Participants
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
n=15 Participants
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Findings in Pulse Oximetry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 16Population: As per the judgement of the safety committee, the Part 2 (MAD) was not conducted based on protocol defined criteria. Hence, this outcome was not assessed as Part 2 of the study was not conducted.
WI-NRS measure was used determine the severity of itch experienced by participants with hepatic impairment (for Cohort 6 only) at screening. Participants were to complete the two forms (the "Night-time Itch" and the "Daytime Itch") at the same time during the screening visit and the average was taken to determine the baseline severity. The scale was a 0 to 10 rating scale with 10 being the most severe itch experienced and 0 being no itching experienced. Higher score indicated greater severity of itching.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: NAL ER 27 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: NAL ER 54 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3: NAL ER 108 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 4: NAL ER 162 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 5: NAL ER 162 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: NAL ER 27 mg
n=16 participants at risk
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose of 27 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 2: NAL ER 54 mg
n=15 participants at risk
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 54 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 3: NAL ER 108 mg
n=15 participants at risk
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 108 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 4: NAL ER 162 mg
n=13 participants at risk
Participants with mild (group 1) and moderate (group 2) hepatic impairment received single dose of 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
Cohort 5: NAL ER 162 mg
n=8 participants at risk
Healthy participants with normal hepatic function (group 4) received up to 162 mg of NAL ER tablet on Day 1 under fasting conditions.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
6.7%
1/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
6.7%
1/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
6.2%
1/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
6.7%
1/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
12.5%
1/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
6.7%
1/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
7.7%
1/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
37.5%
3/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
6.7%
1/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
12.5%
1/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
15.4%
2/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
Psychiatric disorders
Euphoric Mood
|
0.00%
0/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
13.3%
2/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
53.8%
7/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
General disorders
Feeling of Relaxation
|
0.00%
0/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
25.0%
2/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
6.7%
1/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
7.7%
1/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
20.0%
3/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
40.0%
6/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
23.1%
3/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
25.0%
2/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
13.3%
2/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
6.7%
1/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/15 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
7.7%
1/13 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
0.00%
0/8 • From the time of signing informed consent form to Day 4
SAS included all enrolled participants who had received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place