Trial Outcomes & Findings for Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment (NCT NCT03289234)

NCT ID: NCT03289234

Last Updated: 2026-01-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 22 participants
• Primary outcome timeframe: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
• Results posted on: 2026-01-08

Participant Flow

Participant milestones

Measure	Mild Hepatic Impairment Child-Pugh score of 5 or 6	Moderate Hepatic Impairment Child-Pugh score between 7 and 9	Normal Hepatic Function normal hepatic function
Overall Study STARTED	8	6	8
Overall Study COMPLETED	8	6	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment

Baseline characteristics by cohort

Measure	Mild Hepatic Impairment n=8 Participants Child-Pugh score of 5 or 6	Moderate Hepatic Impairment n=6 Participants Child-Pugh score between 7 and 9	Normal Hepatic Function n=8 Participants normal hepatic function	Total n=22 Participants Total of all reporting groups
Age, Continuous	59.6 years STANDARD_DEVIATION 11.9 • n=18 Participants	66.2 years STANDARD_DEVIATION 5.3 • n=17 Participants	61.6 years STANDARD_DEVIATION 2.7 • n=35 Participants	62.1 years STANDARD_DEVIATION 8 • n=42 Participants
Sex: Female, Male Female	2 Participants n=18 Participants	1 Participants n=17 Participants	2 Participants n=35 Participants	5 Participants n=42 Participants
Sex: Female, Male Male	6 Participants n=18 Participants	5 Participants n=17 Participants	6 Participants n=35 Participants	17 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	8 Participants n=18 Participants	6 Participants n=17 Participants	8 Participants n=35 Participants	22 Participants n=42 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	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants
Race (NIH/OMB) White	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Population: PK population

Outcome measures

Measure	Mild Hepatic Impairment n=8 Participants Child-Pugh score of 5 or 6	Moderate Hepatic Impairment n=6 Participants Child-Pugh score between 7 and 9	Normal Hepatic Function n=8 Participants normal hepatic function
Cmax	538.1 ng/mL Standard Deviation 182.3	533.4 ng/mL Standard Deviation 88.57	429 ng/mL Standard Deviation 44.36

PRIMARY outcome

Timeframe: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Population: PK population

Outcome measures

Measure	Mild Hepatic Impairment n=8 Participants Child-Pugh score of 5 or 6	Moderate Hepatic Impairment n=6 Participants Child-Pugh score between 7 and 9	Normal Hepatic Function n=8 Participants normal hepatic function
AUC0-last	716.86 ng*hr/mL Standard Deviation 258.3	739.28 ng*hr/mL Standard Deviation 146.89	582.89 ng*hr/mL Standard Deviation 58.33

PRIMARY outcome

Timeframe: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Population: PK population

Outcome measures

Measure	Mild Hepatic Impairment n=8 Participants Child-Pugh score of 5 or 6	Moderate Hepatic Impairment n=6 Participants Child-Pugh score between 7 and 9	Normal Hepatic Function n=8 Participants normal hepatic function
AUC0-∞	727.55 ng*hr/mL Standard Deviation 262.04	751.52 ng*hr/mL Standard Deviation 148.34	594.96 ng*hr/mL Standard Deviation 63.58

SECONDARY outcome

Timeframe: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Population: PK population

Outcome measures

Measure	Mild Hepatic Impairment n=8 Participants Child-Pugh score of 5 or 6	Moderate Hepatic Impairment n=6 Participants Child-Pugh score between 7 and 9	Normal Hepatic Function n=8 Participants normal hepatic function
t½	3.14 hour Standard Deviation 0.58	4.37 hour Standard Deviation 1.9	5.41 hour Standard Deviation 6.58

Adverse Events

Mild Hepatic Impairment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moderate Hepatic Impairment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Normal Hepatic Function

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mild Hepatic Impairment n=8 participants at risk Child-Pugh score of 5 or 6	Moderate Hepatic Impairment n=6 participants at risk Child-Pugh score between 7 and 9	Normal Hepatic Function n=8 participants at risk normal hepatic function
General disorders Chest pain	0.00% 0/8 • 7 days	16.7% 1/6 • 7 days	0.00% 0/8 • 7 days

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Phone: Please Email

Email: cti-inq-ml.JP@ml.tanabe-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER