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PK Study in Subjects With Severe Hepatic Impairment (MCI-186-E05 HP)

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ClinicalTrials.gov Identifier: NCT03664544
Recruitment Status : Completed
First Posted : September 10, 2018
Results First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Severe Hepatic Impairment
Healthy
Intervention Drug: MCI-186
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description Subjects with severe hepatic impairment Subjects with normal hepatic function
Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title HP PK MCI-186 NHV PK MCI-186 Total
Hide Arm/Group Description Subjects with severe hepatic impairment Subjects with normal hepatic function Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
Safety Analysis Set
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  66.7%
5
  83.3%
9
  75.0%
>=65 years
2
  33.3%
1
  16.7%
3
  25.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
62.2  (7.9) 53.0  (8.0) 57.6  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
1
  16.7%
1
  16.7%
2
  16.7%
Male
5
  83.3%
5
  83.3%
10
  83.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
6
 100.0%
12
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
6
 100.0%
6
 100.0%
12
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Pharmacokinetic Parameters of MCI-186: Peak Drug Concentration (Cmax)
Hide Description Unchanged MCI-186
Time Frame Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
347.6  (146.8) 280.3  (101.0)
2.Primary Outcome
Title Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
Hide Description Unchanged MCI-186
Time Frame Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
473.90  (163.28) 394.65  (160.01)
3.Primary Outcome
Title Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞)
Hide Description Unchanged MCI-186
Time Frame Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
496.98  (183.81) 416.34  (164.96)
4.Secondary Outcome
Title Incidence of Adverse Events (AEs) and Serious Adverse Events
Hide Description Number of adverse events
Time Frame Day -1 to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: Events
Adverse events 0 1
Serious adverse events 0 0
Treatment emergent adverse events 0 1
Adverse Drug reaction 0 1
TEAE leading to discontinuation of study drug 0 0
5.Secondary Outcome
Title Pharmacokinetic Parameters of MCI-186: Half-life (t½)
Hide Description Unchanged MCI-186
Time Frame Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: h
3.88  (1.12) 9.51  (6.62)
6.Secondary Outcome
Title Pharmacokinetic Parameters of MCI-186: Time to Reach Peak Concentration (Tmax)
Hide Description Unchanged MCI-186
Time Frame Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Median (Full Range)
Unit of Measure: h
1.02
(0.25 to 1.05)
1.02
(1.00 to 1.03)
7.Secondary Outcome
Title Pharmacokinetic Parameters of MCI-186: Terminal Elimination Rate Constant (λZ)
Hide Description Unchanged MCI-186
Time Frame Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: /h
0.19  (0.06) 0.15  (0.14)
8.Secondary Outcome
Title Pharmacokinetic Parameters of MCI-186: Total Clearance (CL)
Hide Description Unchanged MCI-186
Time Frame Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: L/h
66.82  (21.49) 78.72  (20.51)
9.Secondary Outcome
Title Pharmacokinetic Parameters of MCI-186: Volume of Distribution at Steady State (Vss)
Hide Description Unchanged MCI-186
Time Frame Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: L
133.86  (71.05) 449.79  (438.26)
10.Secondary Outcome
Title Pharmacokinetic Parameters of MCI-186: Volume of Distribution During the Terminal Phase (VZ)
Hide Description Unchanged MCI-186
Time Frame Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: L
359.85  (130.06) 1064.88  (888.10)
11.Secondary Outcome
Title Pharmacokinetic Parameters of MCI-186: Mean Residence Time (MRT)
Hide Description Unchanged MCI-186
Time Frame Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: h
2.27  (1.87) 5.51  (4.60)
12.Secondary Outcome
Title Pharmacokinetic Parameters of MCI-186: Unbound Area Under the Concentration-time Curve From Time Zero to Infinity (AUCu0-∞)
Hide Description Unchanged MCI-186
Time Frame Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
65.41  (28.71) 45.33  (13.97)
13.Secondary Outcome
Title Pharmacokinetic Parameters of MCI-186: Unbound Total Clearance (Clu)
Hide Description Unchanged MCI-186
Time Frame Day 1 to 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK population
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description:
Subjects with severe hepatic impairment
Subjects with normal hepatic function
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: L/h
529.83  (200.93) 702.10  (159.63)
Time Frame Day -1 to Day 7
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HP PK MCI-186 NHV PK MCI-186
Hide Arm/Group Description Subjects with severe hepatic impairment Subjects with normal hepatic function
All-Cause Mortality
HP PK MCI-186 NHV PK MCI-186
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
HP PK MCI-186 NHV PK MCI-186
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HP PK MCI-186 NHV PK MCI-186
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   1/6 (16.67%) 
Cardiac disorders     
Sinus Bradycardia  1  0/6 (0.00%)  1/6 (16.67%) 
1
Term from vocabulary, MedDra v. 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: General Information
Organization: Mitsubishi Tanabe Pharma Europe Ltd
Phone: Please e-mail
EMail: regulatory@mt-pharma-eu.com
Layout table for additonal information
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03664544    
Other Study ID Numbers: MCI-186-E05
2018-001163-23 ( EudraCT Number )
First Submitted: August 27, 2018
First Posted: September 10, 2018
Results First Submitted: March 24, 2020
Results First Posted: April 7, 2020
Last Update Posted: April 7, 2020