Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia

NCT02078310 | Completed Phase 1 FDA Drug

• 1 other identifier: ITI-007-200
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients with Dementia

Conditions

Alzheimer's Disease

Keywords

Dementia,; Healthy; geriatric; volunteers; patients

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.

  up to 7 days

Secondary Outcomes (1)

• Area under the concentration-time curve (AUC)

  pre-dose and multiple collection points up to 72 h after the last dose

Other Outcomes (3)

• Exploratory measures of cognitive function

  Baseline and up to 7 days

• Exploratory measures of agitation

  Baseline and up to 7 days

• Exploratory measures of subjective sleep

  Baseline and up to 7 days

Study Arms (4)

ITI-007 Part 1

EXPERIMENTAL

Part 1: Healthy geriatric volunteers with multiple oral dose escalation up to and including 20 mg ITI-007

Drug: ITI-007

Placebo Part 1

PLACEBO COMPARATOR

Part 1: Healthy geriatric volunteers with placebo given

Drug: Placebo

ITI-007 Part 2

EXPERIMENTAL

Part 2: Geriatric patients with dementia with ITI-007 given

Drug: ITI-007

Placebo Part 2

PLACEBO COMPARATOR

Part 2: Geriatric patients with dementia with placebo given

Drug: Placebo

Interventions

ITI-007 DRUG

ITI-007 for Part 1

ITI-007 Part 1

Placebo DRUG

ITI-007 for Part 1

Placebo Part 1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Part 1
• Healthy geriatric volunteers
• MMSE score of \>= 26 at screening
• BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening
• Part 2
• Geriatric patients with a clinical diagnosis of dementia
• MMSE score of \< 26 at screening
• BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening

You may not qualify if:

• Any clinically significant illness within 6 months before screening
• Any history of cancer within last 5 years
• History of Hepatitis B or C infection and elevated ALT, AST or bilirubin above the upper limit of normal level
• Any subject considered to be an imminent danger to themselves or others

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (1)

Unknown Facility

Glendale, California, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 5, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 17, 2017

Record last verified: 2014-11

Locations

US (1)