SchizophreniaPhase 1NCT01074073
Lithium Drug-Drug Interaction Study With Lurasidone HCl
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
The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Oct 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.
- Females who participate in this study:
- are unable to have children-OR-
- are willing to remain abstinent from Day -5 until 90 days after discharge;
- Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until 90 days after discharge.
- Able and agree to remain off of prior antipsychotic medication for the duration of the study.
Who cannot join
- 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.
- Positive test results within 30 days prior to the start of the study for:
- Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
- Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day - 5 to follow-up
- Use of a monoamine oxidase inhibitor within 21 days prior to Day 1 to Restabilization.
- Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, 2-Period, Sequential, Drug-Drug Interaction Study To Determine The Effect Of Lithium 600 Mg BID On The Safety And Pharmacokinetics Of Lurasidone 120 Mg QD In Patients With Schizophrenia Or Schizoaffective Disorder
The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and Lurasidone HCl.
Read the detailed description
To compare the steady state pharmacokinetic profile of lurasidone 120 mg QD when administered alone vs. the steady state pharmacokinetic profile of lurasidone 120 mg QD when coadministered with steady state lithium 600 mg BID.
- Conditions
- Schizophrenia
- Being tested
- Lurasidone HCl
- Keywords
- Lithium DDI with Lurasidone HCl, Male/Female, 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
lurasidone HCl 40 mg tablets administered orally as three tablets (120 mg) once a day (QD).
Lithium 300 mg capsules administered orally as two capsules (600 mg) twice a day (BID).
On dosing days, breakfast will be served 30 minutes prior to the planned dosing time. Patients must consume the breakfast within 30 minutes or less. Dosing will take place 30 minutes after the start of breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Lithium/Lurasidone | Other | Schizophrenia Patients 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 posted24 Feb 2010 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionOct 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marina Bussel, MD, Principal investigator, CCT/Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074073
- Sponsor's protocol ID
- D1050247
- Status last verified
- Sep 2011
- First submitted
- 22 Feb 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
- A Phase 1, Open-Label, 2-Period, Sequential, Drug-Drug Interaction Study To Determine The Effect Of Lithium 600 Mg BID On The Safety And Pharmacokinetics Of Lurasidone 120 Mg QD In Patients With Schizophrenia Or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT01074073
- Acronym / sponsor ID
- D1050247
- Conditions
- Schizophrenia
- Keywords
- Lithium DDI with Lurasidone HCl, Male/Female, Schizophrenia Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 24 Feb 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.
The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and Lurasidone HCl.
Detailed description
To compare the steady state pharmacokinetic profile of lurasidone 120 mg QD when administered alone vs. the steady state pharmacokinetic profile of lurasidone 120 mg QD when coadministered with steady state lithium 600 mg BID.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lithium/Lurasidone | Other | Drug: Lurasidone HClSchizophrenia Patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform.
- Females who participate in this study:
- Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until 90 days after discharge.
- Able and agree to remain off of prior antipsychotic medication for the duration of the study.
Key exclusion criteria (6 listed)
- 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.
- Positive test results within 30 days prior to the start of the study for:
- Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
- Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day - 5 to follow-up
- Use of a monoamine oxidase inhibitor within 21 days prior to Day 1 to Restabilization.
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 HCllurasidone HCl 40 mg tablets administered orally as three tablets (120 mg) once a day (QD). Lithium 300 mg capsules administered orally as two capsules (600 mg) twice a day (BID). On dosing days, breakfast will be served 30 minutes prior to the planned dosing time. Patients must consume the breakfast within 30 minutes or less. Dosing will take place 30 minutes after the start of breakfast. | Drug | Lithium/Lurasidone |
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.
Marina Bussel, MD principal investigator
CCT/Parexel
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 6 inclusion and 6 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.