Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study Evaluating the of OPC-34712 in Subjects With Normal Hepatic Function and Hepatically Impaired Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01299454
First received: February 16, 2011
Last updated: September 29, 2015
Last verified: September 2015
Results First Received: August 4, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: OPC-34712

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
81 participants were screened; of these 45 participants were enrolled recruited at 3 study sites in the United States (US).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Mild Hepatic Impairment Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 milligrams (mg).
Moderate Hepatic Impairment Participants with moderate hepatic impairment (Child-Pugh classification scheme)received a single dose of oral brexpiprazole 2 mg.
Severe Hepatic Impairment Participants with severe hepatic impairment (based on Child-Pugh classification scheme) received a single dose of oral brexpiprazole 2 mg.
Normal Hepatic Function Participants with normal hepatic function (based on Child-Pugh classification scheme) received a single dose of oral brexpiprazole 2 mg.

Participant Flow:   Overall Study
    Mild Hepatic Impairment     Moderate Hepatic Impairment     Severe Hepatic Impairment     Normal Hepatic Function  
STARTED     8     8     6     23  
COMPLETED     8     8     6     23  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mild Hepatic Impairment Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
Moderate Hepatic Impairment Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
Severe Hepatic Impairment Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
Normal Hepatic Function Participants with normal hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
Total Total of all reporting groups

Baseline Measures
    Mild Hepatic Impairment     Moderate Hepatic Impairment     Severe Hepatic Impairment     Normal Hepatic Function     Total  
Number of Participants  
[units: participants]
  8     8     6     23     45  
Age  
[units: Years]
Mean (Standard Deviation)
  59.5  (7.3)     57.8  (3.8)     51.2  (4.4)     56.2  (5.2)     56.4  (5.7)  
Gender  
[units: participants]
         
Female     3     2     0     5     10  
Male     5     6     6     18     35  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Unbound Brexpiprazole Area Under the Concentration Time Curve (AUC) Calculated to the Last Observable Concentration at Time t (AUCt,u)   [ Time Frame: Day 1 to Day 8 ]

2.  Primary:   Unbound Brexpiprazole AUC Calculated From Time Zero to Infinity (AUC∞,u)   [ Time Frame: Day 1 to Day 8 ]

3.  Primary:   Unbound Maximum Plasma Concentration of Brexpiprazole (Cmax,u)   [ Time Frame: Day 1 to Day 8 ]

4.  Secondary:   Area Under the Curve of Brexpiprazole Calculated to the Last Observable Concentration at Time t (AUCt)   [ Time Frame: Day 1 to Day 8 ]

5.  Secondary:   Area Under the Concentration Time Curve of Brexpiprazole From Time Zero to Infinity (AUC∞)   [ Time Frame: Day 1 to Day 8 ]

6.  Secondary:   Maximum Plasma Concentration of Brexpiprazole (Cmax)   [ Time Frame: Day 1 to Day 8 ]

7.  Secondary:   Time to Cmax of Brexiprazole (Tmax)   [ Time Frame: Day 1 to Day 8 ]

8.  Secondary:   Apparent Clearance of Brexpiprazole From Plasma After Extravascular Administration (CL/F)   [ Time Frame: Day 1 to Day 8 ]

9.  Secondary:   Unbound Fraction of Brexpiprazole in Plasma (fu)   [ Time Frame: Day 1 to Day 8 ]

10.  Secondary:   Apparent Unbound Clearance of Brexpiprazole From Plasma After Extravascular Administration (CLu/F)   [ Time Frame: Day 1 to Day 8 ]

11.  Secondary:   Terminal-phase Elimination Half-life of Brexpiprazole (t1/2,z)   [ Time Frame: Day 1 to Day 8 ]

12.  Secondary:   Renal Clearance (CLr) of Brexipiprazole   [ Time Frame: Day 1 to Day 8 ]

13.  Secondary:   Cumulative Amount of Brexpiprazole Excreted Into the Urine (Ae,u)   [ Time Frame: Day 1 to Day 8 ]

14.  Secondary:   Fraction of Systemically Available Brexpiprazole Excreted Into the Urine (fe,u)   [ Time Frame: Day 1 to Day 8 ]

15.  Secondary:   AUCt for DM-3411 Metabolite   [ Time Frame: Day 1 to Day 8 ]

16.  Secondary:   AUC∞ for DM-3411 Metabolite   [ Time Frame: Day 1 to Day 8 ]

17.  Secondary:   Cmax for DM-3411 Metabolite   [ Time Frame: Day 1 to Day 8 ]

18.  Secondary:   Tmax for DM-3411 Metabolite   [ Time Frame: Day 1 to Day 8 ]

19.  Secondary:   t1/2,z for DM-3411 Metabolite   [ Time Frame: Day 1 to Day 8 ]

20.  Secondary:   Ae,u for DM-3411 Metabolite   [ Time Frame: Day 1 to Day 8 ]

21.  Secondary:   fe,u for DM-3411 Metabolite   [ Time Frame: Day 1 to Day 8 ]

22.  Secondary:   CLr for DM-3411 Metabolite   [ Time Frame: Day 1 to Day 8 ]

23.  Secondary:   Number of Adverse Events (AEs) Reported   [ Time Frame: From the time the Informed Consent Form was signed, throughout the 8 day study up to 30 days after study drug administration. ]

24.  Secondary:   Number of Participants With Changes From Baseline in Vital Signs Parameters.   [ Time Frame: Day -1 to Day 8 ]

25.  Secondary:   Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Parameters.   [ Time Frame: Day-1 to Day 8 ]

26.  Secondary:   Number of Participants With Changes From Baseline in Serum Chemistry, Hematology and Urinalysis Parameters.   [ Time Frame: Day -1 to Day 8 ]

27.  Secondary:   Incidence of Suicidality, Suicidal Behaviour or Suicidal Ideation as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Day 1, Day 4, Day 7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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:  
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
phone: 800-562-3974



Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01299454     History of Changes
Other Study ID Numbers: 331-09-225
Study First Received: February 16, 2011
Results First Received: August 4, 2015
Last Updated: September 29, 2015
Health Authority: United States: Food and Drug Administration