Trial Outcomes & Findings for PK Study in Subjects With Severe Hepatic Impairment (NCT NCT03664544)
NCT ID: NCT03664544
Last Updated: 2026-01-08
Results Overview
Unchanged MCI-186
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Results posted on
2026-01-08
Participant Flow
Participant milestones
| Measure |
HP PK MCI-186
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1.
|
NHV PK MCI-186
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PK Study in Subjects With Severe Hepatic Impairment
Baseline characteristics by cohort
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=18 Participants
|
5 Participants
n=17 Participants
|
9 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=18 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=35 Participants
|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 7.9 • n=18 Participants
|
53.0 years
STANDARD_DEVIATION 8.0 • n=17 Participants
|
57.6 years
STANDARD_DEVIATION 9.0 • n=35 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=18 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=18 Participants
|
5 Participants
n=17 Participants
|
10 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=18 Participants
|
6 Participants
n=17 Participants
|
12 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=18 Participants
|
6 Participants
n=17 Participants
|
12 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)Population: PK population
Unchanged MCI-186
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Pharmacokinetic Parameters of MCI-186: Peak Drug Concentration (Cmax)
|
347.6 ng/mL
Standard Deviation 146.8
|
280.3 ng/mL
Standard Deviation 101.0
|
PRIMARY outcome
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)Population: PK population
Unchanged MCI-186
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
|
473.90 h*ng/mL
Standard Deviation 163.28
|
394.65 h*ng/mL
Standard Deviation 160.01
|
PRIMARY outcome
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)Population: PK population
Unchanged MCI-186
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞)
|
496.98 h*ng/mL
Standard Deviation 183.81
|
416.34 h*ng/mL
Standard Deviation 164.96
|
SECONDARY outcome
Timeframe: Day -1 to Day 7Population: Safety Analysis Set
Number of adverse events
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events
Adverse events
|
0 Events
|
1 Events
|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events
Serious adverse events
|
0 Events
|
0 Events
|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events
Treatment emergent adverse events
|
0 Events
|
1 Events
|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events
Adverse Drug reaction
|
0 Events
|
1 Events
|
|
Incidence of Adverse Events (AEs) and Serious Adverse Events
TEAE leading to discontinuation of study drug
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)Population: PK population
Unchanged MCI-186
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Pharmacokinetic Parameters of MCI-186: Half-life (t½)
|
3.88 h
Standard Deviation 1.12
|
9.51 h
Standard Deviation 6.62
|
SECONDARY outcome
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)Population: PK population
Unchanged MCI-186
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Pharmacokinetic Parameters of MCI-186: Time to Reach Peak Concentration (Tmax)
|
1.02 h
Interval 0.25 to 1.05
|
1.02 h
Interval 1.0 to 1.03
|
SECONDARY outcome
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)Population: PK population
Unchanged MCI-186
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Pharmacokinetic Parameters of MCI-186: Terminal Elimination Rate Constant (λZ)
|
0.19 /h
Standard Deviation 0.06
|
0.15 /h
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)Population: PK population
Unchanged MCI-186
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Pharmacokinetic Parameters of MCI-186: Total Clearance (CL)
|
66.82 L/h
Standard Deviation 21.49
|
78.72 L/h
Standard Deviation 20.51
|
SECONDARY outcome
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)Population: PK population
Unchanged MCI-186
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Pharmacokinetic Parameters of MCI-186: Volume of Distribution at Steady State (Vss)
|
133.86 L
Standard Deviation 71.05
|
449.79 L
Standard Deviation 438.26
|
SECONDARY outcome
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)Population: PK population
Unchanged MCI-186
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Pharmacokinetic Parameters of MCI-186: Volume of Distribution During the Terminal Phase (VZ)
|
359.85 L
Standard Deviation 130.06
|
1064.88 L
Standard Deviation 888.10
|
SECONDARY outcome
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)Population: PK population
Unchanged MCI-186
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Pharmacokinetic Parameters of MCI-186: Mean Residence Time (MRT)
|
2.27 h
Standard Deviation 1.87
|
5.51 h
Standard Deviation 4.60
|
SECONDARY outcome
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)Population: PK population
Unchanged MCI-186
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Pharmacokinetic Parameters of MCI-186: Unbound Area Under the Concentration-time Curve From Time Zero to Infinity (AUCu0-∞)
|
65.41 h*ng/mL
Standard Deviation 28.71
|
45.33 h*ng/mL
Standard Deviation 13.97
|
SECONDARY outcome
Timeframe: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)Population: PK population
Unchanged MCI-186
Outcome measures
| Measure |
HP PK MCI-186
n=6 Participants
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 Participants
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Pharmacokinetic Parameters of MCI-186: Unbound Total Clearance (Clu)
|
529.83 L/h
Standard Deviation 200.93
|
702.10 L/h
Standard Deviation 159.63
|
Adverse Events
HP PK MCI-186
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NHV PK MCI-186
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HP PK MCI-186
n=6 participants at risk
Subjects with severe hepatic impairment (A Child-Pugh classification score of 10 to 14) were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
NHV PK MCI-186
n=6 participants at risk
Subjects with normal hepatic function were intravenously administered 30 mg MCI-186 over 60 minutes on the morning of Day 1
|
|---|---|---|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/6 • Day -1 to Day 7
|
16.7%
1/6 • Day -1 to Day 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER