Trial Outcomes & Findings for Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects (NCT NCT01846455)
NCT ID: NCT01846455
Last Updated: 2016-10-24
Results Overview
AUC0-last was calculated for buprenorphine, norbuprenorphine, naloxone, and naloxone-3-β-D-glucuronide using non-compartmental analysis: AUC0-last = AUC from time 0 to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing
Results posted on
2016-10-24
Participant Flow
Participant milestones
| Measure |
Hepatic Impairment: Child-Pugh A
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
8
|
10
|
8
|
|
Overall Study
PK Population
|
6
|
7
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
8
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
Baseline characteristics by cohort
| Measure |
Hepatic Impairment: Child-Pugh A
n=9 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
n=8 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
n=8 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
n=10 Participants
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
n=8 Participants
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
n=93 Participants
|
58.6 years
n=4 Participants
|
53.9 years
n=27 Participants
|
53.0 years
n=483 Participants
|
57.1 years
n=36 Participants
|
56.0 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
18 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
25 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
6 participants
n=93 Participants
|
7 participants
n=4 Participants
|
8 participants
n=27 Participants
|
8 participants
n=483 Participants
|
7 participants
n=36 Participants
|
36 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
1 participants
n=36 Participants
|
5 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
0 participants
n=36 Participants
|
2 participants
n=10 Participants
|
|
Weight
|
74.2 kg
n=93 Participants
|
75.4 kg
n=4 Participants
|
82.2 kg
n=27 Participants
|
74.7 kg
n=483 Participants
|
76.6 kg
n=36 Participants
|
76.5 kg
n=10 Participants
|
|
Body Mass Index
|
25.5 kg/m^2
n=93 Participants
|
27.0 kg/m^2
n=4 Participants
|
27.9 kg/m^2
n=27 Participants
|
26.2 kg/m^2
n=483 Participants
|
29.3 kg/m^2
n=36 Participants
|
27.1 kg/m^2
n=10 Participants
|
PRIMARY outcome
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosingPopulation: The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.
AUC0-last was calculated for buprenorphine, norbuprenorphine, naloxone, and naloxone-3-β-D-glucuronide using non-compartmental analysis: AUC0-last = AUC from time 0 to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule.
Outcome measures
| Measure |
Hepatic Impairment: Child-Pugh A
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
n=7 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
n=6 Participants
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
n=8 Participants
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone-3-β-D-Glucuronide
|
19.3 ng*hr/mL
Geometric Coefficient of Variation 31.9
|
27.9 ng*hr/mL
Geometric Coefficient of Variation 33.6
|
20.6 ng*hr/mL
Geometric Coefficient of Variation 40.2
|
19.1 ng*hr/mL
Geometric Coefficient of Variation 21.8
|
22.5 ng*hr/mL
Geometric Coefficient of Variation 15.8
|
|
Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Buprenorphine
|
8.89 ng*hr/mL
Geometric Coefficient of Variation 33.3
|
14.7 ng*hr/mL
Geometric Coefficient of Variation 55.0
|
25.2 ng*hr/mL
Geometric Coefficient of Variation 53.7
|
7.02 ng*hr/mL
Geometric Coefficient of Variation 36.5
|
8.95 ng*hr/mL
Geometric Coefficient of Variation 49.4
|
|
Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Norbuprenorphine
|
12.5 ng*hr/mL
Geometric Coefficient of Variation 119
|
9.51 ng*hr/mL
Geometric Coefficient of Variation 71.4
|
2.25 ng*hr/mL
Geometric Coefficient of Variation 118
|
9.91 ng*hr/mL
Geometric Coefficient of Variation 43.4
|
15.0 ng*hr/mL
Geometric Coefficient of Variation 51.8
|
|
Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone
|
0.0726 ng*hr/mL
Geometric Coefficient of Variation 41.8
|
0.291 ng*hr/mL
Geometric Coefficient of Variation 195
|
1.28 ng*hr/mL
Geometric Coefficient of Variation 60.2
|
0.0968 ng*hr/mL
Geometric Coefficient of Variation 73.0
|
0.0915 ng*hr/mL
Geometric Coefficient of Variation 50.9
|
PRIMARY outcome
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosingPopulation: The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.
Outcome measures
| Measure |
Hepatic Impairment: Child-Pugh A
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
n=7 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
n=6 Participants
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
n=8 Participants
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Buprenorphine
|
1.10 ng/mL
Geometric Coefficient of Variation 52.2
|
1.04 ng/mL
Geometric Coefficient of Variation 46.5
|
1.40 ng/mL
Geometric Coefficient of Variation 27.4
|
0.933 ng/mL
Geometric Coefficient of Variation 30.5
|
0.913 ng/mL
Geometric Coefficient of Variation 53.2
|
|
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Norbuprenorphine
|
0.358 ng/mL
Geometric Coefficient of Variation 99.0
|
0.180 ng/mL
Geometric Coefficient of Variation 73.2
|
0.128 ng/mL
Geometric Coefficient of Variation 60.6
|
0.203 ng/mL
Geometric Coefficient of Variation 61.0
|
0.265 ng/mL
Geometric Coefficient of Variation 59.8
|
|
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone
|
0.0287 ng/mL
Geometric Coefficient of Variation 62.7
|
0.0773 ng/mL
Geometric Coefficient of Variation 159
|
0.323 ng/mL
Geometric Coefficient of Variation 28.7
|
0.0361 ng/mL
Geometric Coefficient of Variation 83.8
|
0.0286 ng/mL
Geometric Coefficient of Variation 68.1
|
|
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone-3-β-D-Glucuronide
|
9.02 ng/mL
Geometric Coefficient of Variation 29.8
|
9.03 ng/mL
Geometric Coefficient of Variation 21.8
|
6.75 ng/mL
Geometric Coefficient of Variation 40.0
|
6.80 ng/mL
Geometric Coefficient of Variation 14.7
|
8.12 ng/mL
Geometric Coefficient of Variation 30.5
|
PRIMARY outcome
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosingPopulation: The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.
The extrapolation to infinity was done using the terminal phase. AUC0-inf = AUC0-last + Ct/λz Where Ct was the last observed quantifiable concentration and λz was the apparent terminal phase elimination rate constant.
Outcome measures
| Measure |
Hepatic Impairment: Child-Pugh A
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
n=7 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
n=6 Participants
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
n=8 Participants
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Buprenorphine (5,4,5,3,6)
|
11.0 ng*hr/mL
Geometric Coefficient of Variation 30.8
|
18.9 ng*hr/mL
Geometric Coefficient of Variation 58.4
|
25.5 ng*hr/mL
Geometric Coefficient of Variation 44.6
|
8.61 ng*hr/mL
Geometric Coefficient of Variation 22.6
|
10.3 ng*hr/mL
Geometric Coefficient of Variation 56.0
|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Norbuprenorphine (3,3,1,3,3)
|
25.4 ng*hr/mL
Geometric Coefficient of Variation 25.5
|
17.1 ng*hr/mL
Geometric Coefficient of Variation 77.4
|
6.67 ng*hr/mL
Geometric Coefficient of Variation NA
Value is for a single participant
|
13.9 ng*hr/mL
Geometric Coefficient of Variation 58.6
|
16.0 ng*hr/mL
Geometric Coefficient of Variation 23.0
|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone (5,6,5,4,7)
|
0.0671 ng*hr/mL
Geometric Coefficient of Variation 18.7
|
0.274 ng*hr/mL
Geometric Coefficient of Variation 195
|
1.45 ng*hr/mL
Geometric Coefficient of Variation 57.0
|
0.0851 ng*hr/mL
Geometric Coefficient of Variation 57.0
|
0.0971 ng*hr/mL
Geometric Coefficient of Variation 53.4
|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone-3-β-D-Glucuronide (5,7,6,5,4)
|
21.9 ng*hr/mL
Geometric Coefficient of Variation 28.0
|
28.9 ng*hr/mL
Geometric Coefficient of Variation 32.7
|
21.3 ng*hr/mL
Geometric Coefficient of Variation 38.5
|
21.5 ng*hr/mL
Geometric Coefficient of Variation 15.0
|
26.0 ng*hr/mL
Geometric Coefficient of Variation 12.4
|
PRIMARY outcome
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosingPopulation: The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.
Outcome measures
| Measure |
Hepatic Impairment: Child-Pugh A
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
n=7 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
n=6 Participants
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
n=8 Participants
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
|---|---|---|---|---|---|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Buprenorphine
|
1.25 hours
Interval 1.0 to 2.0
|
1.50 hours
Interval 0.5 to 2.0
|
1.00 hours
Interval 0.5 to 2.0
|
1.38 hours
Interval 1.0 to 1.5
|
1.75 hours
Interval 1.0 to 3.0
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Norbuprenorphine
|
1.25 hours
Interval 1.0 to 1.25
|
1.25 hours
Interval 1.0 to 36.0
|
0.875 hours
Interval 0.5 to 6.0
|
1.00 hours
Interval 1.0 to 36.0
|
1.00 hours
Interval 1.0 to 2.0
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone
|
0.875 hours
Interval 0.5 to 1.25
|
0.750 hours
Interval 0.5 to 1.5
|
0.750 hours
Interval 0.25 to 1.25
|
1.00 hours
Interval 0.5 to 1.0
|
1.13 hours
Interval 0.5 to 2.0
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone-3-β-D-Glucuronide
|
0.500 hours
Interval 0.5 to 1.0
|
0.750 hours
Interval 0.5 to 0.75
|
0.500 hours
Interval 0.5 to 0.767
|
0.750 hours
Interval 0.75 to 1.0
|
0.500 hours
Interval 0.5 to 1.5
|
PRIMARY outcome
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosingPopulation: The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.
Outcome measures
| Measure |
Hepatic Impairment: Child-Pugh A
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
n=7 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
n=6 Participants
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
n=8 Participants
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
|---|---|---|---|---|---|
|
Time of the Last Measureable Plasma Concentration (Tlast) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone-3-β-D-Glucuronide
|
24.0 hours
Interval 12.0 to 36.0
|
24.1 hours
Interval 12.0 to 36.0
|
24.0 hours
Interval 12.0 to 36.0
|
36.0 hours
Interval 24.0 to 36.0
|
36.0 hours
Interval 24.0 to 72.0
|
|
Time of the Last Measureable Plasma Concentration (Tlast) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Buprenorphine
|
72.0 hours
Interval 48.0 to 96.0
|
120 hours
Interval 72.0 to 168.0
|
168 hours
Interval 96.0 to 168.0
|
71.5 hours
Interval 36.0 to 97.0
|
96.0 hours
Interval 36.0 to 144.0
|
|
Time of the Last Measureable Plasma Concentration (Tlast) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Norbuprenorphine
|
144 hours
Interval 72.0 to 168.0
|
120 hours
Interval 72.0 to 168.0
|
48.0 hours
Interval 12.0 to 96.0
|
144 hours
Interval 119.0 to 169.0
|
156 hours
Interval 120.0 to 168.0
|
|
Time of the Last Measureable Plasma Concentration (Tlast) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone
|
10.0 hours
Interval 6.03 to 12.0
|
24.0 hours
Interval 12.0 to 36.0
|
24.0 hours
Interval 24.0 to 48.0
|
10.0 hours
Interval 8.0 to 24.0
|
10.0 hours
Interval 6.0 to 24.0
|
PRIMARY outcome
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosingPopulation: The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.
Calculated as: (AUC0-inf - AUC0-last)/AUC0-inf \* 100 AUC0-inf, apparent body clearance (CL/F), and apparent volume of distribution during terminal phase (Vz/F) would not have been reported if %AUCextrap was \> 20%.
Outcome measures
| Measure |
Hepatic Impairment: Child-Pugh A
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
n=7 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
n=6 Participants
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
n=8 Participants
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Area Under the Concentration-time Curve From Time Zero to Infinity Due to Extrapolation (%AUCextrap) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Norbuprenorphine (4,6,5,4,4)
|
10.2 percentage of AUC0-inf
Standard Deviation 8.67
|
24.3 percentage of AUC0-inf
Standard Deviation 12.4
|
36.1 percentage of AUC0-inf
Standard Deviation 18.0
|
16.5 percentage of AUC0-inf
Standard Deviation 3.85
|
13.1 percentage of AUC0-inf
Standard Deviation 9.24
|
|
Percentage of Area Under the Concentration-time Curve From Time Zero to Infinity Due to Extrapolation (%AUCextrap) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Buprenorphine (6,5,5,5,7)
|
17.2 percentage of AUC0-inf
Standard Deviation 10.8
|
17.1 percentage of AUC0-inf
Standard Deviation 6.68
|
14.2 percentage of AUC0-inf
Standard Deviation 3.00
|
17.6 percentage of AUC0-inf
Standard Deviation 4.96
|
15.5 percentage of AUC0-inf
Standard Deviation 5.00
|
|
Percentage of Area Under the Concentration-time Curve From Time Zero to Infinity Due to Extrapolation (%AUCextrap) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone (5,6,5,4,7)
|
6.59 percentage of AUC0-inf
Standard Deviation 1.86
|
7.48 percentage of AUC0-inf
Standard Deviation 6.18
|
1.30 percentage of AUC0-inf
Standard Deviation 0.958
|
5.16 percentage of AUC0-inf
Standard Deviation 5.01
|
5.31 percentage of AUC0-inf
Standard Deviation 2.51
|
|
Percentage of Area Under the Concentration-time Curve From Time Zero to Infinity Due to Extrapolation (%AUCextrap) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone-3-β-D-Glucuronide (5,7,6,5,4)
|
4.98 percentage of AUC0-inf
Standard Deviation 1.74
|
3.34 percentage of AUC0-inf
Standard Deviation 1.53
|
3.50 percentage of AUC0-inf
Standard Deviation 2.08
|
6.04 percentage of AUC0-inf
Standard Deviation 3.60
|
5.13 percentage of AUC0-inf
Standard Deviation 3.55
|
PRIMARY outcome
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosingPopulation: The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.
For the determination of λz, only those data points judged to describe the terminal log-linear decline resulting in an adjusted coefficient of determination value (R2) \> 0.7 were used in the regression. A minimum of 3 data points were used in calculating λz.
Outcome measures
| Measure |
Hepatic Impairment: Child-Pugh A
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
n=7 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
n=6 Participants
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
n=8 Participants
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
|---|---|---|---|---|---|
|
Terminal Phase Elimination Rate-Constant (λz) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone (5,6,5,4,7)
|
0.322 1/hour
Geometric Coefficient of Variation 23.0
|
0.127 1/hour
Geometric Coefficient of Variation 53.6
|
0.151 1/hour
Geometric Coefficient of Variation 28.2
|
0.371 1/hour
Geometric Coefficient of Variation 35.6
|
0.337 1/hour
Geometric Coefficient of Variation 35.6
|
|
Terminal Phase Elimination Rate-Constant (λz) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Buprenorphine (6,5,5,5,7)
|
0.0221 1/hour
Geometric Coefficient of Variation 46.0
|
0.0142 1/hour
Geometric Coefficient of Variation 41.0
|
0.0123 1/hour
Geometric Coefficient of Variation 29.5
|
0.0197 1/hour
Geometric Coefficient of Variation 32.6
|
0.0193 1/hour
Geometric Coefficient of Variation 50.2
|
|
Terminal Phase Elimination Rate-Constant (λz) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Norbuprenorphine (4,6,5,4,4)
|
0.0168 1/hour
Geometric Coefficient of Variation 39.4
|
0.0131 1/hour
Geometric Coefficient of Variation 21.5
|
0.0189 1/hour
Geometric Coefficient of Variation 37.4
|
0.0135 1/hour
Geometric Coefficient of Variation 7.37
|
0.0167 1/hour
Geometric Coefficient of Variation 36.0
|
|
Terminal Phase Elimination Rate-Constant (λz) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone-3-β-D-Glucuronide (5,7,6,5,4)
|
0.0974 1/hour
Geometric Coefficient of Variation 26.0
|
0.117 1/hour
Geometric Coefficient of Variation 32.5
|
0.152 1/hour
Geometric Coefficient of Variation 40.4
|
0.0637 1/hour
Geometric Coefficient of Variation 41.9
|
0.0937 1/hour
Geometric Coefficient of Variation 69.4
|
PRIMARY outcome
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosingPopulation: The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.
Terminal elimination half-life, calculated as ln(2)/λz. The terminal phase elimination half-life was calculated over a period of at least 2 half-lives.
Outcome measures
| Measure |
Hepatic Impairment: Child-Pugh A
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
n=7 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
n=6 Participants
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
n=8 Participants
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Buprenorphine (6,5,5,5,7)
|
31.4 hours
Geometric Coefficient of Variation 46.0
|
48.7 hours
Geometric Coefficient of Variation 41.0
|
56.4 hours
Geometric Coefficient of Variation 29.5
|
35.2 hours
Geometric Coefficient of Variation 32.6
|
36.0 hours
Geometric Coefficient of Variation 50.2
|
|
Terminal Elimination Half-life (t1/2) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone-3-β-D-Glucuronide (5,7,6,5,4)
|
7.12 hours
Geometric Coefficient of Variation 26.0
|
5.91 hours
Geometric Coefficient of Variation 32.5
|
4.55 hours
Geometric Coefficient of Variation 40.4
|
10.9 hours
Geometric Coefficient of Variation 41.9
|
7.40 hours
Geometric Coefficient of Variation 69.4
|
|
Terminal Elimination Half-life (t1/2) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Norbuprenorphine (4,6,5,4,4)
|
41.3 hours
Geometric Coefficient of Variation 39.4
|
52.9 hours
Geometric Coefficient of Variation 21.5
|
36.7 hours
Geometric Coefficient of Variation 37.4
|
51.2 hours
Geometric Coefficient of Variation 7.37
|
41.4 hours
Geometric Coefficient of Variation 36.0
|
|
Terminal Elimination Half-life (t1/2) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide
Naloxone (5,6,5,4,7)
|
2.15 hours
Geometric Coefficient of Variation 23.0
|
5.45 hours
Geometric Coefficient of Variation 53.6
|
4.58 hours
Geometric Coefficient of Variation 28.2
|
1.87 hours
Geometric Coefficient of Variation 35.6
|
2.06 hours
Geometric Coefficient of Variation 35.6
|
PRIMARY outcome
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosingPopulation: The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.
Apparent body clearance (only for buprenorphine and naloxone), calculated as Dose/AUC0-inf.
Outcome measures
| Measure |
Hepatic Impairment: Child-Pugh A
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
n=7 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
n=6 Participants
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
n=8 Participants
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
|---|---|---|---|---|---|
|
Apparent Body Clearance (CL/F) of Buprenorphine and Naloxone
Buprenorphine (5,4,5,3,6)
|
182 L/hr
Geometric Coefficient of Variation 30.8
|
106 L/hr
Geometric Coefficient of Variation 58.4
|
78.3 L/hr
Geometric Coefficient of Variation 44.6
|
232 L/hr
Geometric Coefficient of Variation 22.6
|
193 L/hr
Geometric Coefficient of Variation 56.0
|
|
Apparent Body Clearance (CL/F) of Buprenorphine and Naloxone
Naloxone (5,6,5,4,7)
|
7448 L/hr
Geometric Coefficient of Variation 18.7
|
1824 L/hr
Geometric Coefficient of Variation 195
|
344 L/hr
Geometric Coefficient of Variation 57.0
|
5874 L/hr
Geometric Coefficient of Variation 57.0
|
5148 L/hr
Geometric Coefficient of Variation 53.4
|
PRIMARY outcome
Timeframe: before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosingPopulation: The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.
Apparent volume of distribution during terminal phase (only for buprenorphine and naloxone), calculated as Dose/(λz • AUC0-inf).
Outcome measures
| Measure |
Hepatic Impairment: Child-Pugh A
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
n=7 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
n=6 Participants
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
n=6 Participants
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
n=8 Participants
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Buprenorphine and Naloxone
Naloxone (5,6,5,4,7)
|
23150 Liters
Geometric Coefficient of Variation 28.1
|
14353 Liters
Geometric Coefficient of Variation 187
|
2272 Liters
Geometric Coefficient of Variation 66.7
|
15845 Liters
Geometric Coefficient of Variation 97.9
|
15294 Liters
Geometric Coefficient of Variation 42.8
|
|
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Buprenorphine and Naloxone
Buprenorphine (5,4,5,3,6)
|
7226 Liters
Geometric Coefficient of Variation 26.1
|
6959 Liters
Geometric Coefficient of Variation 42.6
|
6373 Liters
Geometric Coefficient of Variation 28.9
|
9580 Liters
Geometric Coefficient of Variation 29.1
|
9176 Liters
Geometric Coefficient of Variation 21.9
|
Adverse Events
Hepatic Impairment: Child-Pugh A
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Hepatic Impairment: Child-Pugh B
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Hepatic Impairment: Child-Pugh C
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
HCV Without Hepatic Impairment
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
No Hepatic Disease or Impairment
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hepatic Impairment: Child-Pugh A
n=9 participants at risk
Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh B
n=8 participants at risk
Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
Hepatic Impairment: Child-Pugh C
n=8 participants at risk
Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
HCV Without Hepatic Impairment
n=10 participants at risk
Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
No Hepatic Disease or Impairment
n=8 participants at risk
Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
55.6%
5/9 • Days 1 - 21
|
25.0%
2/8 • Days 1 - 21
|
50.0%
4/8 • Days 1 - 21
|
40.0%
4/10 • Days 1 - 21
|
62.5%
5/8 • Days 1 - 21
|
|
Nervous system disorders
Somnolence
|
33.3%
3/9 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
10.0%
1/10 • Days 1 - 21
|
37.5%
3/8 • Days 1 - 21
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Days 1 - 21
|
25.0%
2/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
20.0%
2/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
Nervous system disorders
Dysarthria
|
11.1%
1/9 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
0.00%
0/10 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/9 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
10.0%
1/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
Nervous system disorders
Asterixis
|
0.00%
0/9 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
0.00%
0/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/9 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
0.00%
0/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/9 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
0.00%
0/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/9 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
0.00%
0/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
Nervous system disorders
Sedation
|
0.00%
0/9 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
0.00%
0/10 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
|
Gastrointestinal disorders
Vomiting
|
44.4%
4/9 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
50.0%
5/10 • Days 1 - 21
|
37.5%
3/8 • Days 1 - 21
|
|
Gastrointestinal disorders
Nausea
|
55.6%
5/9 • Days 1 - 21
|
25.0%
2/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
20.0%
2/10 • Days 1 - 21
|
37.5%
3/8 • Days 1 - 21
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Days 1 - 21
|
37.5%
3/8 • Days 1 - 21
|
25.0%
2/8 • Days 1 - 21
|
20.0%
2/10 • Days 1 - 21
|
37.5%
3/8 • Days 1 - 21
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
20.0%
2/10 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
0.00%
0/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
0.00%
0/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
1/9 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
0.00%
0/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
General disorders
Fatigue
|
0.00%
0/9 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
50.0%
5/10 • Days 1 - 21
|
37.5%
3/8 • Days 1 - 21
|
|
General disorders
Chills
|
11.1%
1/9 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
10.0%
1/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
3/9 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
50.0%
4/8 • Days 1 - 21
|
10.0%
1/10 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
10.0%
1/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
1/9 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
0.00%
0/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
Psychiatric disorders
Euphoric mood
|
11.1%
1/9 • Days 1 - 21
|
25.0%
2/8 • Days 1 - 21
|
50.0%
4/8 • Days 1 - 21
|
10.0%
1/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/9 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
12.5%
1/8 • Days 1 - 21
|
0.00%
0/10 • Days 1 - 21
|
0.00%
0/8 • Days 1 - 21
|
Additional Information
Reckitt Benckiser Pharmaceuticals, Inc.
RECKITT BENCKISER PHARMACEUTICALS, INC.
Phone: 804-379-1090
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60