SchizophreniaPhase 1ACP-104NCT00628420
Safety Study of ACP-104: To Demonstrate the Safety, Tolerability, and Pharmacokinetics
A Phase 1 study testing ACP-104 in people with Schizophrenia, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- ACP-104
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Oct 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veteran's Affairs Medical Center
Dallas, Texas, 75216
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- ACP-104, Placebo
- Keywords
- Schizophrenia, N-desmethylclozapine, clozapine, psychosis, randomized, placebo studies
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-104Drug
25mg, 75mg, 125mg, 175mg, 225mg, or 275mg once a day for 2 weeks
ACP-104Drug
Patient will be given either 50mg, 100mg, 150mg, 200mg, 250mg, or 300mg daily for 2 weeks
PlaceboDrug
Also called cornstarch capsule
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Patients recieved single low dose of ACP-104 Receives: Drug: ACP-104 |
| 2 | Other | Patients recieved a high dose of ACP-104 Receives: Drug: ACP-104 |
| 3 | Other | Patients recieved a placebo Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startJan 2005
- Primary completionNov 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute, ACADIA Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628420
- Sponsor's protocol ID
- 082004-051
- Acronym
- ACP-104
- Status last verified
- Feb 2008
- First submitted
- 24 Feb 2008
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00628420
- Acronym / sponsor ID
- ACP-104 / 082004-051
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, N-desmethylclozapine, clozapine, psychosis, randomized, placebo studies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute, ACADIA Pharmaceuticals Inc.
- Study start
- Jan 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: ACP-104Patients recieved single low dose of ACP-104 |
| 2 | Other | Drug: ACP-104Patients recieved a high dose of ACP-104 |
| 3 | Other | Drug: PlaceboPatients recieved a placebo |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP-10425mg, 75mg, 125mg, 175mg, 225mg, or 275mg once a day for 2 weeks | Drug | 1 |
| ACP-104Patient will be given either 50mg, 100mg, 150mg, 200mg, 250mg, or 300mg daily for 2 weeks | Drug | 2 |
| PlaceboAlso: cornstarch capsulepatients 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. | Drug | 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACP-104 in people with Schizophrenia, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.