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

NCT02078310 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-11-17

No results posted yet for this study

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

Interventions

DRUG

ITI-007

ITI-007 for Part 1

DRUG

Placebo

ITI-007 for Part 1

DRUG

ITI-007

ITI-007 for Part 2

DRUG

Placebo

Placebo for Part 2

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-08-31
Completion
2014-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02078310 on ClinicalTrials.gov