- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00628420
Safety Study of ACP-104: To Demonstrate the Safety, Tolerability, and Pharmacokinetics (ACP-104)
June 27, 2011 updated by: University of Texas Southwestern Medical Center
A Randomized, Double Blind, Placebo Controlled, Single Oral Dose Study to Demonstrate the Safety, Tolerability, and Pharmacokinetics of ACP-104 (N-desmethylclozapine) in Schizophrenia, or Other Psychotic Disorders.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Thirty-six healthy patients with schizophrenia or psychotic disorders, each of whom will be drug-free at study initiation, will be admitted to the hospital and will each receive two doses of ACP-104, and one dose of placebo, orally every 3-5 days over a two-week period.
The patients will be divided into six groups of up to six and minimum of 3 patients each.
Group 1 will consist of six patients who will receive single 25mg and 50mg doses of ACP-104 and placebo in random, but rising dose, order over a two-week period.
Data from group one will be collected to determine ACP-104's safety, tolerability, and pharmacokinetics.
Group 2 will be enrolled in the study once study data from Group 1 has demonstrated the safety of ACP-104.
Group 2 will receive a 25mg pre-conditioning dose of ACP-104.
Following the pre-conditioning dose, 75mg and 100mg single doses of ACP-104 will be administered in random, but rising dose, order, over a two-week period.
Group 3 will be enrolled in the study once study data from Group 2 has demonstrated the safety of ACP-104.
Group 3 will receive a 25mg pre-conditioning dose of ACP-104.
Following the pre-conditioning dose, 125mg and 150mg single doses of ACP-104 will be administered in random, but rising dose, order, over a two-week period.
Group 4 will be enrolled in the study once study data from Group 3 has demonstrated the safety of ACP-104.
Group 4 will receive a 25mg pre-conditioning dose of ACP-104.
Following the pre-conditioning dose, 175mg and 200mg single doses of ACP-104 will be administered in random, but rising dose, order, over a two-week period.
Group 5 will be enrolled in the study once study data from Group 4 has demonstrated the safety of ACP-104.
Group 5 will receive a 25mg pre-conditioning dose of ACP-104.
Following the pre-conditioning dose, 225mg and 250mg single doses of ACP-104 will be administered in random, but rising dose, order, over a two week period.
Group 6 will be enrolled in the study once study data from Group 5 has demonstrated the safety of ACP-104.
Group 6 will receive a 25mg pre-conditioning dose of ACP-104.
Following the pre-conditioning dose, 275mg and 300mg single doses of ACP-104 will be administered in random, but rising dose, order, over a two-week period.
Groups 1-6 will be monitored closely and safety procedures and evaluations will be performed on all medication days.
Safety assessments will include: physical examinations, vital signs (3-positional blood pressure and pulse rate, respiration rate, and oral body temperature), clinical laboratory tests, ECGs (Electrocardiogram), coordination tests, questions about symptoms and side effects.
Once all medication days have been completed, the condition of the patient will be assessed, and, at that time, it will be determined whether the patient's condition is suitable for release from the hospital or whether further monitoring of the patient's condition as an inpatient is needed.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- The University of Texas Southwestern Medical Center
-
Dallas, Texas, United States, 75216
- Veteran's Affairs Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
Patients recieved single low dose of ACP-104
|
25mg, 75mg, 125mg, 175mg, 225mg, or 275mg once a day for 2 weeks
Patient will be given either 50mg, 100mg, 150mg, 200mg, 250mg, or 300mg daily for 2 weeks
|
Other: 2
Patients recieved a high dose of ACP-104
|
25mg, 75mg, 125mg, 175mg, 225mg, or 275mg once a day for 2 weeks
Patient will be given either 50mg, 100mg, 150mg, 200mg, 250mg, or 300mg daily for 2 weeks
|
Other: 3
Patients recieved a 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.
Other Names:
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
February 24, 2008
First Submitted That Met QC Criteria
February 24, 2008
First Posted (Estimate)
March 5, 2008
Study Record Updates
Last Update Posted (Estimate)
June 28, 2011
Last Update Submitted That Met QC Criteria
June 27, 2011
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 082004-051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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