SchizophreniaPhase 1NCT04709224
Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia
A Phase 1 study testing Lumateperone Long-Acting Injectable in people with Schizophrenia, run by Intra-Cellular Therapies, Inc. at 2 sites in United States.
Trial summary
This is an open-label study to determine the pharmacokinetics, safety and tolerability of single ascending doses of lumateperone long-acting injectable formulation in patients with schizophrenia. Patients will be enrolled in one of up to four cohorts. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lumateperone Long-Acting Injectable
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Dec 2020to 23 May 2022
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients aged 18 to 50 years, inclusive
- Clinical diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to Screening per Investigator assessment
- On a stable dose of antipsychotic medication, including lumateperone, for at least 3 months prior to the Screening Visit
- Clinical Global Impression - Severity (CGI-S) score ≤ 3
Who cannot join
- Clinically significant abnormality within 2 years of Screening that, in the Investigator's opinion, may place the patient at risk or interfere with study outcome variables
- History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study
- Any suicidal ideation within the 6 months prior to Screening, any suicidal behavior within 2 years prior to Screening based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigator assessment that the patient is a safety risk to him/herself or others
- Surgical or medical condition (active or chronic) that in the Investigator's opinion may interfere with drug absorption, distribution, metabolism, or excretion of the study drug or any other condition that may place the patient at risk; history of gastric bypass or sleeve gastrectomy; history of severe dystonic reaction on antipsychotics such as laryngeal spasm
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Site
Long Beach, California, 90806
Clinical Site
Marlton, New Jersey, 08053
About this study
Official title: An Open-label Study to Determine the Pharmacokinetics, Safety and Tolerability of Single Ascending Doses of a Subcutaneous Injection of Lumateperone Long-Acting Injectable (LAI) Formulation in Patients With Schizophrenia
This is an open-label study to determine the pharmacokinetics, safety and tolerability of single ascending doses of lumateperone long-acting injectable formulation in patients with schizophrenia. Patients will be enrolled in one of up to four cohorts. All patients will receive oral lumateperone for 5 days, followed by a 5-day washout of oral lumateperone, then followed by a single dose of lumateperone LAI.
- Conditions
- Schizophrenia
- Being tested
- Lumateperone Long-Acting Injectable
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumateperone Long-Acting InjectableDrug
Lumateperone Long-Acting Injectable
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: LAI Lumateperone 50 mg SC in the abdomen | Experimental | Not described Receives: Drug: Lumateperone Long-Acting Injectable |
| Cohort 2: LAI Lumateperone 100 mg SC in the abdomen | Experimental | Not described Receives: Drug: Lumateperone Long-Acting Injectable |
| Cohort 3: LAI Lumateperone 200 mg SC in the abdomen | Experimental | Not described Receives: Drug: Lumateperone Long-Acting Injectable |
| Cohort 4: LAI Lumateperone 100 or 200 mg SC in the outer area of the upper arm | Experimental | Not described Receives: Drug: Lumateperone Long-Acting Injectable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Maximum observed plasma concentration (Cmax) of lumateperone and metabolites
Measured: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Time of maximum observed plasma concentration (Tmax) of lumateperone and metabolites
Measured: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of lumateperone and metabolites
Measured: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of lumateperone and metabolites
Measured: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Terminal elimination half-life (T1/2) of lumateperone and metabolites
Measured: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Maximum observed plasma concentration (Cmax,BR) of lumateperone and metabolites during burst-release phase
Measured: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Time of maximum observed plasma concentration (Tmax,BR) of lumateperone and metabolites during burst-release phase
Measured: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Area under the plasma concentration-time curve (AUC0-t,BR) of lumateperone and metabolites during burst-release phase
Measured: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Maximum observed plasma concentration (Cmax,SR) of lumateperone and metabolites during sustained-release phase
Measured: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Time of maximum observed plasma concentration (Tmax,SR) of lumateperone and metabolites during sustained-release phase
Measured: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Area under the plasma concentration-time curve (AUC0-t,SR) of lumateperone and metabolites during sustained-release phase
Measured: predose and at multiple timepoints up to 7 weeks postdose
Secondary outcomes (11)
Percentage of participants with treatment-emergent AEs
Measured: up to 7 weeks postdose
Change from baseline in Systolic and Diastolic Blood Pressure
Measured: up to 7 weeks postdose
Change from baseline in hemoglobin
Measured: up to 7 weeks postdose
Change from baseline in platelet count
Measured: up to 7 weeks postdose
Change from baseline in white blood cell count
Measured: up to 7 weeks postdose
Change from baseline in aspartate aminotransferase
Measured: up to 7 weeks postdose
Change from baseline in alanine aminotransferase
Measured: up to 7 weeks postdose
Change from baseline in glucose
Measured: up to 7 weeks postdose
Change from baseline in creatine kinase
Measured: up to 7 weeks postdose
Change from baseline in ECG QT Interval
Measured: up to 7 weeks postdose
Change from baseline in Abnormal Involuntary Movement Scale
AIMS is a measure of facial and oral movements, extremity movements and trunk movements. Items are rated on a scale from none (0) to severe (4).
Measured: up to 7 weeks postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start30 Dec 2020
- Primary completion23 May 2022
- Study completion23 May 2022
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 Intra-Cellular Therapies, Inc.The 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709224
- Sponsor's protocol ID
- ITI-007-025
- Status last verified
- Dec 2022
- First submitted
- 29 Dec 2020
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Determine the Pharmacokinetics, Safety and Tolerability of Single Ascending Doses of a Subcutaneous Injection of Lumateperone Long-Acting Injectable (LAI) Formulation in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT04709224
- Acronym / sponsor ID
- ITI-007-025
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 14 Jan 2021 (actual)
- 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.
This is an open-label study to determine the pharmacokinetics, safety and tolerability of single ascending doses of lumateperone long-acting injectable formulation in patients with schizophrenia. Patients will be enrolled in one of up to four cohorts. All patients will receive oral lumateperone for 5 days, followed by a 5-day washout of oral lumateperone, then followed by a single dose of lumateperone LAI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: LAI Lumateperone 50 mg SC in the abdomen | Experimental | Drug: Lumateperone Long-Acting Injectable |
| Cohort 2: LAI Lumateperone 100 mg SC in the abdomen | Experimental | Drug: Lumateperone Long-Acting Injectable |
| Cohort 3: LAI Lumateperone 200 mg SC in the abdomen | Experimental | Drug: Lumateperone Long-Acting Injectable |
| Cohort 4: LAI Lumateperone 100 or 200 mg SC in the outer area of the upper arm | Experimental | Drug: Lumateperone Long-Acting Injectable |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female patients aged 18 to 50 years, inclusive
- Clinical diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to Screening per Investigator assessment
- On a stable dose of antipsychotic medication, including lumateperone, for at least 3 months prior to the Screening Visit
- Clinical Global Impression - Severity (CGI-S) score ≤ 3
Key exclusion criteria (4 listed)
- Clinically significant abnormality within 2 years of Screening that, in the Investigator's opinion, may place the patient at risk or interfere with study outcome variables
- History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study
- Any suicidal ideation within the 6 months prior to Screening, any suicidal behavior within 2 years prior to Screening based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigator assessment that the patient is a safety risk to him/herself or others
- Surgical or medical condition (active or chronic) that in the Investigator's opinion may interfere with drug absorption, distribution, metabolism, or excretion of the study drug or any other condition that may place the patient at risk; history of gastric bypass or sleeve gastrectomy; history of severe dystonic reaction on antipsychotics such as laryngeal spasm
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 |
|---|---|---|
| Lumateperone Long-Acting InjectableLumateperone Long-Acting Injectable | Drug | Cohort 1: LAI Lumateperone 50 mg SC in the abdomen, Cohort 2: LAI Lumateperone 100 mg SC in the abdomen, Cohort 3: LAI Lumateperone 200 mg SC in the abdomen, Cohort 4: LAI Lumateperone 100 or 200 mg SC in the outer area of the upper arm |
Primary outcome
Pharmacokinetics: Maximum observed plasma concentration (Cmax) of lumateperone and metabolites
Time frame: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Time of maximum observed plasma concentration (Tmax) of lumateperone and metabolites
Time frame: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of lumateperone and metabolites
Time frame: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of lumateperone and metabolites
Time frame: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Terminal elimination half-life (T1/2) of lumateperone and metabolites
Time frame: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Maximum observed plasma concentration (Cmax,BR) of lumateperone and metabolites during burst-release phase
Time frame: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Time of maximum observed plasma concentration (Tmax,BR) of lumateperone and metabolites during burst-release phase
Time frame: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Area under the plasma concentration-time curve (AUC0-t,BR) of lumateperone and metabolites during burst-release phase
Time frame: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Maximum observed plasma concentration (Cmax,SR) of lumateperone and metabolites during sustained-release phase
Time frame: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Time of maximum observed plasma concentration (Tmax,SR) of lumateperone and metabolites during sustained-release phase
Time frame: predose and at multiple timepoints up to 7 weeks postdose
Pharmacokinetics: Area under the plasma concentration-time curve (AUC0-t,SR) of lumateperone and metabolites during sustained-release phase
Time frame: predose and at multiple timepoints up to 7 weeks postdose
11 secondary outcomes
Percentage of participants with treatment-emergent AEs
Time frame: up to 7 weeks postdose
Change from baseline in Systolic and Diastolic Blood Pressure
Time frame: up to 7 weeks postdose
Change from baseline in hemoglobin
Time frame: up to 7 weeks postdose
Change from baseline in platelet count
Time frame: up to 7 weeks postdose
Change from baseline in white blood cell count
Time frame: up to 7 weeks postdose
Change from baseline in aspartate aminotransferase
Time frame: up to 7 weeks postdose
Change from baseline in alanine aminotransferase
Time frame: up to 7 weeks postdose
Change from baseline in glucose
Time frame: up to 7 weeks postdose
Change from baseline in creatine kinase
Time frame: up to 7 weeks postdose
Change from baseline in ECG QT Interval
Time frame: up to 7 weeks postdose
Change from baseline in Abnormal Involuntary Movement Scale
Time frame: up to 7 weeks postdose
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 5 Dec 2022.
- Individual participant dataSharing planned: No
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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 Lumateperone Long-Acting Injectable in people with Schizophrenia, run by Intra-Cellular Therapies, Inc. 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 5 inclusion and 4 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 5 Dec 2022. 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.
What does the primary outcome measure?
Pharmacokinetics: Maximum observed plasma concentration (Cmax) of lumateperone and metabolites (time frame: predose and at multiple timepoints up to 7 weeks postdose). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 5 Dec 2022.