Trial Outcomes & Findings for Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment (NCT NCT03289208)
NCT ID: NCT03289208
Last Updated: 2026-01-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 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 Renal Function Group
Mild renal function defined as eGFR 60-89 mL/min/1.73m\^2
|
Moderate Renal Function Group
Moderate renal function defined as eGFR 30-59 mL/min/1.73m\^2
|
Normal Renal Function Group
Normal renal function defined as eGFR ≥90 mL/min/1.73m\^2
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
8
|
11
|
|
Overall Study
COMPLETED
|
10
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Mild Renal Function Group
Mild renal function defined as eGFR 60-89 mL/min/1.73m\^2
|
Moderate Renal Function Group
Moderate renal function defined as eGFR 30-59 mL/min/1.73m\^2
|
Normal Renal Function Group
Normal renal function defined as eGFR ≥90 mL/min/1.73m\^2
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
Baseline characteristics by cohort
| Measure |
Mild Renal Function Group
n=11 Participants
Mild renal function defined as eGFR 60-89 mL/min/1.73m\^2
|
Moderate Renal Function Group
n=8 Participants
Moderate renal function defined as eGFR 30-59 mL/min/1.73m\^2
|
Normal Renal Function Group
n=11 Participants
Normal renal function defined as eGFR ≥90 mL/min/1.73m\^2
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 5.1 • n=18 Participants
|
57.9 years
STANDARD_DEVIATION 8.4 • n=17 Participants
|
47.3 years
STANDARD_DEVIATION 4.3 • n=35 Participants
|
45.8 years
STANDARD_DEVIATION 10.6 • n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=18 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=35 Participants
|
9 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=18 Participants
|
6 Participants
n=17 Participants
|
9 Participants
n=35 Participants
|
21 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
|
11 Participants
n=18 Participants
|
8 Participants
n=17 Participants
|
11 Participants
n=35 Participants
|
30 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-dosePopulation: PK population
Outcome measures
| Measure |
Mild Renal Function Group
n=6 Participants
Mild renal function defined as eGFR 60-89 mL/min/1.73m\^2
|
Moderate Renal Function Group
n=8 Participants
Moderate renal function defined as eGFR 30-59 mL/min/1.73m\^2
|
Normal Renal Function Group
n=8 Participants
Normal renal function defined as eGFR ≥90 mL/min/1.73m\^2
|
|---|---|---|---|
|
Cmax
|
545.4 ng/mL
Standard Deviation 92.59
|
593.2 ng/mL
Standard Deviation 115.4
|
475.9 ng/mL
Standard Deviation 95.32
|
PRIMARY outcome
Timeframe: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dosePopulation: PK population
Outcome measures
| Measure |
Mild Renal Function Group
n=6 Participants
Mild renal function defined as eGFR 60-89 mL/min/1.73m\^2
|
Moderate Renal Function Group
n=8 Participants
Moderate renal function defined as eGFR 30-59 mL/min/1.73m\^2
|
Normal Renal Function Group
n=8 Participants
Normal renal function defined as eGFR ≥90 mL/min/1.73m\^2
|
|---|---|---|---|
|
AUC0-last
|
758 ng*hr/mL
Standard Deviation 148.09
|
808.7 ng*hr/mL
Standard Deviation 152.01
|
638.09 ng*hr/mL
Standard Deviation 151.98
|
PRIMARY outcome
Timeframe: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dosePopulation: PK population
Outcome measures
| Measure |
Mild Renal Function Group
n=6 Participants
Mild renal function defined as eGFR 60-89 mL/min/1.73m\^2
|
Moderate Renal Function Group
n=8 Participants
Moderate renal function defined as eGFR 30-59 mL/min/1.73m\^2
|
Normal Renal Function Group
n=8 Participants
Normal renal function defined as eGFR ≥90 mL/min/1.73m\^2
|
|---|---|---|---|
|
AUC0-∞
|
770.97 ng*hr/mL
Standard Deviation 153.63
|
826.44 ng*hr/mL
Standard Deviation 149.44
|
644.85 ng*hr/mL
Standard Deviation 153.14
|
SECONDARY outcome
Timeframe: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dosePopulation: PK population
Outcome measures
| Measure |
Mild Renal Function Group
n=6 Participants
Mild renal function defined as eGFR 60-89 mL/min/1.73m\^2
|
Moderate Renal Function Group
n=8 Participants
Moderate renal function defined as eGFR 30-59 mL/min/1.73m\^2
|
Normal Renal Function Group
n=8 Participants
Normal renal function defined as eGFR ≥90 mL/min/1.73m\^2
|
|---|---|---|---|
|
t½
|
5.38 hour
Standard Deviation 6.04
|
7.31 hour
Standard Deviation 5.83
|
2.87 hour
Standard Deviation 0.38
|
Adverse Events
Mild Renal Function Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Moderate Renal Function Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Renal Function Group
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 |
Mild Renal Function Group
n=11 participants at risk
Mild renal function defined as eGFR 60-89 mL/min/1.73m\^2
|
Moderate Renal Function Group
n=8 participants at risk
Moderate renal function defined as eGFR 30-59 mL/min/1.73m\^2
|
Normal Renal Function Group
n=11 participants at risk
Normal renal function defined as eGFR ≥90 mL/min/1.73m\^2
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
9.1%
1/11 • 7 days
|
0.00%
0/8 • 7 days
|
0.00%
0/11 • 7 days
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • 7 days
|
0.00%
0/8 • 7 days
|
0.00%
0/11 • 7 days
|
|
Gastrointestinal disorders
Vomitting
|
9.1%
1/11 • 7 days
|
0.00%
0/8 • 7 days
|
0.00%
0/11 • 7 days
|
|
Renal and urinary disorders
Haematuria
|
9.1%
1/11 • 7 days
|
0.00%
0/8 • 7 days
|
0.00%
0/11 • 7 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • 7 days
|
0.00%
0/8 • 7 days
|
9.1%
1/11 • 7 days
|
|
Investigations
Blood bilirubin increased
|
9.1%
1/11 • 7 days
|
0.00%
0/8 • 7 days
|
0.00%
0/11 • 7 days
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma Corporation
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER