Schizophrenia PatientsPhase 1NCT01082263
Midazolam Drug-Drug Interaction Study With Lurasidone HCl
A Phase 1 study testing Lurasidone HCl in people with Schizophrenia Patients, run by Sumitomo Pharma America, Inc. at 1 site in United States.
Trial summary
A Phase I, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Patients
- 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
- Oct 2008to Nov 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
- Females who participate in this study:
- are unable to have children -OR- are willing to remain abstinent from Day -5 to 90 days after discharge; -OR- are willing to use an effective method of double-barrier birth control from Day -5 to 90 days after discharge.
- Males must be willing to remain sexually abstinent or use an effective method of birth control from Day -5 to 90 days after discharge.
- Able and agree to remain off of prior antipsychotic medication for the duration of the study.
Who cannot join
- Known presence or history of renal or hepatic insufficiency.
- A history or presence of abnormal electrocardiogram (ECG5. Known history or presence of clinically significant intolerance to antipsychotic medications.
- 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.
- 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 including but not limited to those listed in Appendix 19.5.
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- Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.
- Difficulty fasting or consuming the FDA high fat meals.
- At risk with midazolam dosing with respiratory disease or impaired gag reflex, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
A Phase I, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl.
Read the detailed description
lurasidone 120 mg, midazolam 5 mg
To compare the single-dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered with a single-dose of lurasidone 120 mg.
To compare the single dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered after steady state dosing with lurasidone 120 mg.
- Conditions
- Schizophrenia Patients
- Being tested
- Lurasidone HCl
- Keywords
- DDI study between Midazolam and Lurasidone HCl, Male and Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurasidone HClDrug
Day1: 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) Day6: 120 mg lurasidone (three 40 mg tablets) + 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) Day 7-12: 120 mg lurasidone (three 40 mg tablets) 120 mg lurasidone (three 40 mg tablets) on Day 13 + 5 mg midazolam (2.5 mL of the 2 mg/mL syrup)
| Study group | Role | What they receive |
|---|---|---|
| Midazolam/Lurasidone | Other | Schizophrenia patient 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 startOct 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia PatientsStudies 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 (estimated)
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
- NCT01082263
- Sponsor's protocol ID
- D1050269
- 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
- Midazolam Drug-Drug Interaction Study With Lurasidone HCl
- ClinicalTrials.gov ID
- NCT01082263
- Acronym / sponsor ID
- D1050269
- Conditions
- Schizophrenia Patients
- Keywords
- DDI study between Midazolam and Lurasidone HCl, Male and Female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 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, Drug-Drug Interaction Study between Midazolam and Lurasidone HCl.
Detailed description
lurasidone 120 mg, midazolam 5 mg
To compare the single-dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered with a single-dose of lurasidone 120 mg.
To compare the single dose pharmacokinetic profile of midazolam 5 mg when administered alone vs. when administered after steady state dosing with lurasidone 120 mg.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midazolam/Lurasidone | Other | Drug: Lurasidone HClSchizophrenia patient |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders
- Females who participate in this study:
- are unable to have children -OR- are willing to remain abstinent from Day -5 to 90 days after discharge; -OR- are willing to use an effective method of double-barrier birth control from Day -5 to 90 days after discharge.
- Males must be willing to remain sexually abstinent or use an effective method of birth control from Day -5 to 90 days after discharge.
- Able and agree to remain off of prior antipsychotic medication for the duration of the study.
Key exclusion criteria (9 listed)
- Known presence or history of renal or hepatic insufficiency.
- A history or presence of abnormal electrocardiogram (ECG5. Known history or presence of clinically significant intolerance to antipsychotic medications.
- 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.
- Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
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 HClDay1: 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) Day6: 120 mg lurasidone (three 40 mg tablets) + 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) Day 7-12: 120 mg lurasidone (three 40 mg tablets) 120 mg lurasidone (three 40 mg tablets) on Day 13 + 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) | Drug | Midazolam/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 Patients, 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 5 inclusion and 9 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.