SchizophreniaPhase 1NCT01082250
The Bioequivalence Of Two Different Lurasidone Formulations In Patients
A Phase 1 study testing Lurasidone HCl in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 1 site in United States.
Trial summary
A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lurasidone HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Sep 2008
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders as per DSM-IV or DSM-IV-TR criteria, which in the opinion of the investigator have been clinically stable for the past 6 months.
- Body mass index (BMI) ≥ 19.5 and ≤ 37 kg/m2.
- No clinically relevant abnormal laboratory values.
- No clinically significant findings in the 12-lead electrocardiogram (ECG):
- No clinically significant findings from a vital signs measurement.
- Able to understand and provide written consent prior to initiating any study procedure after being informed of the nature of the study.
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- Females who participate in this study:
- are unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy); OR
- are willing to remain abstinent [not engage in sexual intercourse] from Day -5 until the final follow-up visit; OR
- are willing to use an effective method of double-barrier birth control (e.g. partner using condom and female using diaphragm, contraceptive sponge, spermicide, or intrauterine device [IUD]) from Day -5 until the final follow-up visit.
- Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until the final follow-up visit.
Who cannot join
- Significant disease(s) or clinically significant finding(s) in a physical examination determined by an Investigator to pose a health concern to the patient while on study.
- Known history or presence of intolerance to psychiatric medications (e.g. atypical antipsychotic medications).
- History of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to study entry.
- Significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 30 mmHg or more and/or drop in diastolic blood pressure of 20 mmHg or more on standing).
- Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
- A history of epilepsy or risk of having seizures.
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- Positive test results within 30 days prior to the start of the study for:
- Human immunodeficiency virus (HIV).
- Hepatitis B surface antigen and Hepatitis C antibody.
- Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
- Serum beta-HCG consistent with pregnancy (females only).
- Participated in another clinical trial or received an investigational product within 30 days prior to Screening.
- Use of any inhibitor or inducer of CYP3A4 taken within 30 days prior to check-in, including but not limited to those listed in Appendix 19.3.
- Difficulty fasting or consuming the standard meals.
- Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
- -OR- Females having used implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
- Donation or loss of whole blood prior to drug administration, as follows:
- ≤ 499 mL within 30 days prior to dosing
- ≥ 500 mL within 56 days prior to dosing.
- Patient has a prolactin concentration ≥ 100 ng/mL at Screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials (CCT)
Glendale, California, 91206
About this study
Official title: AN OPEN-LABEL, RANDOMIZED, THREE-PERIOD, TWO-SEQUENCE CROSSOVER, REPEATED-DOSE, REPLICATE DESIGN STUDY TO DETERMINE THE BIOEQUIVALENCE OF TWO DIFFERENT LURASIDONE FORMULATIONS IN PATIENTS WITH SCHIZOPHRENIA, SCHIZOAFFECTIVE, OR SCHIZOPHRENIFORM DISORDER
A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl
Read the detailed description
12.5% Drugload 3X40mg vs. 25% Drugload 1X120mg
- Conditions
- Schizophrenia
- Being tested
- Lurasidone HCl
- Keywords
- Bioequivalence, Male/Female Patient, Reference/Test Formulation, Schizophrenia Patients
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurasidone HClDrug
120mg dose. 3-way cross-over for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Reference Formulation | Other | Dosed 12.5% drugload 3X40mg Receives: Drug: Lurasidone HCl |
| Test Formulation | Other | 25% Drugload 1X120mg Receives: Drug: Lurasidone HCl |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startJul 2008
- Primary completionSep 2008
- Study completionSep 2008
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.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lev Gertsik, MD, Principal investigator, California Clinical Trials (CCT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082250
- Sponsor's protocol ID
- D1050263
- Status last verified
- Sep 2011
- First submitted
- 5 Mar 2010
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN-LABEL, RANDOMIZED, THREE-PERIOD, TWO-SEQUENCE CROSSOVER, REPEATED-DOSE, REPLICATE DESIGN STUDY TO DETERMINE THE BIOEQUIVALENCE OF TWO DIFFERENT LURASIDONE FORMULATIONS IN PATIENTS WITH SCHIZOPHRENIA, SCHIZOAFFECTIVE, OR SCHIZOPHRENIFORM DISORDER
- ClinicalTrials.gov ID
- NCT01082250
- Acronym / sponsor ID
- D1050263
- Conditions
- Schizophrenia
- Keywords
- Bioequivalence, Male/Female Patient, Reference/Test Formulation, Schizophrenia Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 8 Mar 2010 (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.
A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl
Detailed description
12.5% Drugload 3X40mg vs. 25% Drugload 1X120mg
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Formulation | Other | Drug: Lurasidone HClDosed 12.5% drugload 3X40mg |
| Test Formulation | Other | Drug: Lurasidone HCl25% Drugload 1X120mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders as per DSM-IV or DSM-IV-TR criteria, which in the opinion of the investigator have been clinically stable for the past 6 months.
- Body mass index (BMI) ≥ 19.5 and ≤ 37 kg/m2.
- No clinically relevant abnormal laboratory values.
- No clinically significant findings in the 12-lead electrocardiogram (ECG):
- No clinically significant findings from a vital signs measurement.
Key exclusion criteria (20 listed)
- Significant disease(s) or clinically significant finding(s) in a physical examination determined by an Investigator to pose a health concern to the patient while on study.
- Known history or presence of intolerance to psychiatric medications (e.g. atypical antipsychotic medications).
- History of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to study entry.
- Significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 30 mmHg or more and/or drop in diastolic blood pressure of 20 mmHg or more on standing).
- Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
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 |
|---|---|---|
| Lurasidone HCl120mg dose. 3-way cross-over for 21 days | Drug | Reference Formulation, Test Formulation |
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 8 Sep 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.
Lev Gertsik, MD principal investigator
California Clinical Trials (CCT)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lurasidone HCl in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 1 site 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 11 inclusion and 20 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 8 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 8 Sep 2011.