Safety and Tolerability of Multiple Doses of ITI-214 in Healthy Adults and in Adults With Stable Schizophrenia
|Schizophrenia||Drug: ITI-214 Dose A Drug: ITI-214 Dose B Drug: ITI-214 Dose C Drug: ITI-214 Dose D (Elderly) Drug: Placebo Drug: ITI-214 Dose E Drug: ITI-214 Dose F Drug: ITI-214 Dose G Drug: ITI-214 Dose H||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
|Official Title:||A Phase 1, Randomized, Placebo- Controlled, Double-Blind Safety, Tolerability, Pharmacokinetic, and Exploratory Pharmacodynamic Study in Healthy Subjects and Subjects With Stable Schizophrenia After Multiple Doses of ITI-214|
- Percentage of participants who experience at least one treatment-emergent adverse event (TEAE) [ Time Frame: Day 1 to Day 44 (up to 24 hours postdose) ]A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing.
- Tmax: Time to Reach the Maximum Plasma Concentration [ Time Frame: Days 1 and 14 (up to 24 hours postdose) ]Time to reach the maximum observed plasma concentration for ITI-214F and ITI-214F metabolite IC200338 after a single dose (Day 1) and multiple dosing (Day 14).
- Cmax: Maximum Observed Plasma Concentration [ Time Frame: Days 1 and 14 (up to 24 hours postdose) ]Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Cmax will be measured for ITI-214F and ITI-214F metabolite IC200338 after a single dose (Day 1) and multiple dosing (Day 14).
- AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration [ Time Frame: Days 1 and 14 (up to 24 hours postdose) ]AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the Last Quantifiable Concentration and will be measured for ITI-214F and ITI-214F metabolite IC200338 after a single dose (Day 1) and multiple dosing (Day 14).
- AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose [ Time Frame: Days 1 and 14 (up to 24 hours postdose) ]AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose for ITI-214F and ITI-214F metabolite IC200338 after a single dose (Day 1) and multiple dosing (Day 14).
|Study Start Date:||July 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Multiple Rising Dose (MRD) Phase: Ascending ITI-214 Doses
ITI-214 Doses (A, B, C, D, matching placebo), solution, orally, once daily for 14 days.
Drug: ITI-214 Dose A
ITI-214 Dose A Oral SolutionDrug: ITI-214 Dose B
ITI-214 Oral Solution Dose BDrug: ITI-214 Dose C
ITI-214 Dose C Oral SolutionDrug: ITI-214 Dose D (Elderly)
ITI-214 Dose D (Elderly) Oral SolutionDrug: Placebo
ITI-214 Matching Placebo Oral Solution
Experimental: Neuroimaging Phase: ITI-214 Doses
ITI-214 (E,F, G, H, matching Placebo) Oral solution, once daily for 7 days in 3 periods with placebo and two of the ITI-214 Doses (E, F, G and H) in a cross-over fashion with minimum 7 days washout between periods
Drug: ITI-214 Dose E
ITI-214 Dose E Oral SolutionDrug: ITI-214 Dose F
ITI-214 Dose F Oral SolutionDrug: ITI-214 Dose G
ITI-214 Dose G Oral SolutionDrug: ITI-214 Dose H
ITI-214 Dose H Oral SolutionDrug: Placebo
ITI-214 Matching Placebo Oral Solution
The drug being tested in this study is called ITI-214. This study will look at how well different doses of ITI-214 are tolerated in healthy people and in people with stable schizophrenia. In addition, exploratory neuroimaging will be conducted in participants with schizophrenia.
This multi-center trial will be conducted in the United States. The study will be comprised of 2 parts: Multiple-Rising Dose (MRD) and Neuroimaging (NI). Approximately 40 healthy participants are planned to be enrolled in the MRD part of the study and approximately 36 patients with stable schizophrenia are planned to be enrolled in the Neuroimaging part of the study.
Participants in the MRD (parallel design) part will be enrolled in cohorts for different dose levels. In each dose cohort, participants will be randomly assigned to active dose or placebo—which will remain undisclosed to participants and study doctor during the study (unless there is an urgent medical need). The following dose cohorts will be enrolled: Doses A, B, C, and D.
Participants will be asked to take the study drug in oral solution once daily for a total of 14 days while confined at the study site. Participants will be contacted by telephone 22 and 44 days after last dose of study drug for a follow-up assessment.
Participants in the Neuroimaging (NI) part of the study will be randomly assigned to one of six treatment sequences. Each sequence consists of 3 cross-over treatment periods. The following doses will be tested: Doses E, F, G, and H.
Each participant will undergo 3 treatment periods of placebo or ITI-214 once daily dosing for 7 days in each of the periods. There will be a washout period of a minimum of 7 days between treatment periods. Participants will be confined at the study site for 5 days of each treatment period and will report to the site on other dosing days for study drug administration. There will be follow-up assessments on Days 14 and 37 of Period 3.
Study was terminated due to business decision. The study compound is being transferred to Intra-Cellular Therapies, Inc.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01900522
|United States, California|
|Glendale, California, United States|
|United States, New York|
|New York, New York, United States|
|Study Director:||Medical Director||Takeda|