A Randomized, Double-blind, Placebo-controlled, Multiple Oral Dose Escalation for Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia.
Overview
- Phase
- Phase 1
- Intervention
- ITI-007
- Conditions
- Alzheimer's Disease
- Sponsor
- Intra-Cellular Therapies, Inc.
- Enrollment
- 35
- Primary Endpoint
- Number of participants with adverse events
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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
Arms & Interventions
ITI-007 Part 1
Part 1: Healthy geriatric volunteers with multiple oral dose escalation up to and including 20 mg ITI-007
Intervention: ITI-007
Placebo Part 1
Part 1: Healthy geriatric volunteers with placebo given
Intervention: Placebo
ITI-007 Part 2
Part 2: Geriatric patients with dementia with ITI-007 given
Intervention: ITI-007
Placebo Part 2
Part 2: Geriatric patients with dementia with placebo given
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants with adverse events
Time Frame: up to 7 days
Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.
Secondary Outcomes
- Area under the concentration-time curve (AUC)(pre-dose and multiple collection points up to 72 h after the last dose)