CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 45 enrolled
Drug / intervention
OPC-34712drug
Likely dose
OPC-34712 240 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01299454
NCT01299454Phase 1Completed
CompareCT.gov

A Single-dose, Open-label, Parallel Group, Matched Study Evaluating the Pharmacokinetics of Oral OPC-34712 Tablet in Subjects With Normal Hepatic Function and Hepatically Impaired Subjects

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Feb 18, 2011·Updated Oct 20, 2015

In Brief

A Phase 1 clinical trial evaluating OPC-34712 for Schizophrenia. Completed, enrolled 45 participants across 3 sites.

Detailed Summary

The purpose of this study is to evaluate how much of the investigational product gets into the blood stream and how long the body takes to get rid of it when given to subjects with a range of liver impairment compared to subjects with normal liver function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 18, 2011
Enrollment StartDec 1, 2010
Primary CompletionJun 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.4 years ago

Interventions

OPC-34712drug

All groups will receive a single oral 2-mg OPC-34712 dose on Day 1 with 240 mL room temperature still water. Subjects will be administered the OPC-34712 dose in the fasted state (at least 8 hours of fasting) and no food will be allowed for 4 hours postdose. Water will be restricted as part of the dosing procedure from 1 hour prior to dosing and 2 hours post-dose.