Safety Study of ACP-104: To Demonstrate the Safety, Tolerability, and Pharmacokinetics

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the safety and tolerability of ACP-104 after oral administration of single doses in comparison with placebo to schizophrenia or other psychotic disorders.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: ACADIA Pharmaceuticals Inc.; Stanley Medical Research Institute

Criteria

Inclusion Criteria:

• Males and females, who have been surgically sterilized or at least 1 year post menopausal, in good health (based on medical history, physical examination, electrocardiograms, and clinical laboratory tests)

• Between 20 and 50 years old (inclusive)

• History of schizophrenia, schizoaffective disorder, bipolar with psychosis, major depression with psychosis, PTSD with psychosis, or psychosis NOS and not experiencing an acute exacerbation of severe psychosis

• Able to execute informed written consent

• Willing to follow dietary restrictions as outlined in Section 6.2 General and dietary restrictions,

• Willing to remain hospitalized for the in-patient portion of the study and return for follow up visit(s) as required by the protocol and as deemed necessary by principal investigator,

• Will be in need of treatment with an antipsychotic medication,

• Fluent and literate in English

Exclusion Criteria:

• Any patient that has received clozapine within the last three months, or any depot antipsychotic within the last six months,

• Likely allergy or insensitivity to ACP-104 or clozapine based on known allergies to drugs of the same class, or which in the opinion of the principle investigator, suggests an increased potential for an adverse hypersensitivity to ACP-104

• Any prior history of drug-induced leukopenia or neutropenia,

• Any prior history of neuroleptic malignant syndrome

• History of seizure, epilepsy, severe head injury, multiple sclerosis, or other known neurological condition

• Prior history of cardiovascular disease, including arrhythmia or myocarditis

• Abnormal pre-admission vital signs or clinical laboratory evaluations

• Any patient with a history, within the last three months, of alcohol and/or drug dependency or alcohol and/or drug abuse in the last month

• History of hepatic or renal disease

• Any patient scheduled to undergo any surgical procedure during the duration of the study,

• Any patient taking any concurrent medications for a major medical illness

• Any patient who has donated plasma or blood within 30 days before the first dose of study medication,

• Any patient who has received any known hepatic or renal clearance altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, etc.) for a period of 3 months before the first dose of study medication

• Ingestion or use of any investigational medication or device within 3 months before the first dose of study medication

• Acute illness within 5 days before the first dose of study medication

• Mental capacity is limited to the extent that the patient cannot provide legal consent or understand information regarding the side effects or tolerance of the study drug

• Any patient judged by the principal investigator to be inappropriate for the study.

• We do not have the resources necessary to properly study non-English speaking patients in this study. The need to provide such resources would be prohibitive to the successful completion of the study.