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

NCT00628420 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2011-06-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ACP-104

25mg, 75mg, 125mg, 175mg, 225mg, or 275mg once a day for 2 weeks

DRUG

ACP-104

Patient will be given either 50mg, 100mg, 150mg, 200mg, 250mg, or 300mg daily for 2 weeks

DRUG

Placebo

patients will be given a placebo: 25mg, 50mg, 75mg, 100mg, 125mg, 150mg, 175mg, 200mg, 225mg, 250mg, 275mg, or 300mg (to match the doses given) daily for 2 weeks.

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • ACADIA Pharmaceuticals Inc.

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2006-11-30
Completion
2007-10-31

Countries

  • United States

Study Locations

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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 NCT00628420 on ClinicalTrials.gov