SchizophreniaPhase 1NCT04865835
A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia.
A Phase 1 study testing SEP-363856 and metformin in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 2 sites in United States.
Trial summary
A clinical trial study to determine the effect of an investigational drug (SEP-363856) has on the way that the drug Metformin travels through the body in people with schizophrenia. This clinical trial will have approximately 24 subjects both male and female 18 year of age and older. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SEP-363856 and metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 May 2021to 3 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject between 18 and 65 years of age, inclusive, at the time of informed consent.
- Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM 5) criteria for a primary diagnosis of schizophrenia as established by clinical interview (using the DSM 5 as a reference and confirmed using the Structured Clinical Interview for DSM 5, Clinical Trials Version [SCID CT]).
- Subject must have a Clinical Global Impressions - Severity Scale (CGI S) score ≤ 4 (normal to moderately ill) at Screening.
- Subject must have a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80 at Screening.
- Subject must have a score of ≤ 4 on the following PANSS items at Screening:
- P7 (hostility) G8 (uncooperativeness).
- Subject must have normal to mild symptoms on all individual items of the Simpson-Angus Scale (SAS) (< 2), Abnormal Involuntary Movement Scale (AIMS) (< 3) and Barnes Akathisia Rating Scale (BARS) (< 3) at Screening.
- Subject has been taking an antipsychotic for at least six weeks prior to Screening and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes may be permitted after Medical Monitor and Sponsor review) for at least six weeks prior to Screening.
Who cannot join
- Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study, including any clinically significant hematological (including deep vein thrombosis) or bleeding disorder, renal, metabolic, endocrine, pulmonary, gastrointestinal, urological, cardiovascular, hepatic, neurologic or allergic disease (except for untreated seasonal allergies that are asymptomatic at the time of dosing).
- Subject has a disorder or history of a condition, or previous gastrointestinal surgery (eg, cholecystectomy, vagotomy, bowel resection) that may interfere with drug absorption, distribution, metabolism, excretion, gastrointestinal motility, or pH, or a history of clinically significant abnormality of the hepatic or renal system, or a history of malabsorption (uncomplicated cholecystectomy, appendectomy, and hernia repair will be acceptable).
- Subject has a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
- Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the Columbia-Suicide Severity Rating Scale (C SSRS) at Screening (ie, in the past 1 month) or at any subsequent C SSRS assessment prior to dosing (ie since last visit).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hassman Research Institute
Marlton, New Jersey, 08053
At Fort Lauderdale Behavioral Health Center
Oakland Park, Florida, 33334
About this study
Official title: A Randomized, Single-blind, Two-period Crossover to Investigate the Effect of SEP-363856 on the Pharmacokinetics of Metformin in Subjects With Schizophrenia.
A clinical trial study to determine the effect of an investigational drug (SEP-363856) has on the way that the drug Metformin travels through the body in people with schizophrenia. This clinical trial will have approximately 24 subjects both male and female 18 year of age and older. This study will be conducted in approximately 2 study sites in the United States.
Read the detailed description
This is a randomized, single-blind, two-period crossover study in which each subject will receive both treatments and therefore act as their own control to minimize confounding covariates within the study population. Randomizing subjects to treatment sequence will assist with reducing the potential order effects that might confound the findings if all the subjects received the same treatment sequence. The single-blind method is used to keep subjects blind to treatment assignment throughout the study period, in order to avoid possible influence of the psychological factors of subjects on study assessments. This clinical study will evaluate whether SEP 363856 influences the PK of a concomitantly administered OCT2 substrate, metformin.
- Conditions
- Schizophrenia
- Being tested
- placebo, SEP-363856, metformin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
single dose of placebo
SEP-363856Drug
single dose of SEP 363856 100 mg
metforminDrug
metformin-HCl 850 mg
| Study group | Role | What they receive |
|---|---|---|
| placebo and metformin | Placebo comparator | single dose of placebo + single dose of metformin-HCl 850 mg (approximately 663 mg metformin) (placebo will be dosed 1 hour prior to metformin administration) Receives: Drug: placebo; Drug: metformin |
| SEP-363856 and metformin | Experimental | single dose of SEP 363856 100 mg + single dose of metformin-HCl 850 mg (SEP 363856 will be dosed 1 hour prior to metformin administration) Receives: Drug: SEP-363856; Drug: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve
area under the plasma concentration-time curve from time zero to infinity (AUC0 ∞) or area under the plasma concentration-time curve from time zero to a defined time (AUC0-t), if appropriate
Measured: 72 hours
• maximum observed plasma concentration
maximum observed plasma concentration (Cmax).
Measured: 72 hours
Secondary outcomes (10)
area under the plasma concentration-time curve
area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-last)
Measured: 72 hours
time of the maximum observed plasma concentration
time of the maximum observed plasma concentration (tmax)
Measured: 72 hours
time of last quantifiable concentration
time of last quantifiable concentration (Tlast)
Measured: 72 hours
• percentage of extrapolated AUC0-∞
percentage of extrapolated AUC0-∞ (%AUCextrap)
Measured: 72 hours
terminal elimination half-life
terminal elimination half-life(T1/2)
Measured: 72 hours
apparent clearance
apparent clearance (CL/F)
Measured: 72 hours
apparent volume of distribution
apparent volume of distribution (VZ/F)
Measured: 72 hours
amount excreted in urine
amount excreted in urine (Ae)
Measured: 72 hours
percentage excreted in urine
percentage excreted in urine (Fe)
Measured: 72 hours
renal clearance
renal clearance (CLR)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start12 May 2021
- Primary completion3 May 2022
- Study completion3 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 Otsuka Pharmaceutical Development & Commercialization, 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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, single-blind, two-period crossover study in adults with schizophrenia
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865835
- Sponsor's protocol ID
- SEP361-110
- Status last verified
- Jun 2024
- First submitted
- 26 Apr 2021
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Two-period Crossover to Investigate the Effect of SEP-363856 on the Pharmacokinetics of Metformin in Subjects With Schizophrenia.
- ClinicalTrials.gov ID
- NCT04865835
- Acronym / sponsor ID
- SEP361-110
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 May 2021 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 29 Apr 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.
A clinical trial study to determine the effect of an investigational drug (SEP-363856) has on the way that the drug Metformin travels through the body in people with schizophrenia. This clinical trial will have approximately 24 subjects both male and female 18 year of age and older. This study will be conducted in approximately 2 study sites in the United States.
Detailed description
This is a randomized, single-blind, two-period crossover study in which each subject will receive both treatments and therefore act as their own control to minimize confounding covariates within the study population. Randomizing subjects to treatment sequence will assist with reducing the potential order effects that might confound the findings if all the subjects received the same treatment sequence. The single-blind method is used to keep subjects blind to treatment assignment throughout the study period, in order to avoid possible influence of the psychological factors of subjects on study assessments. This clinical study will evaluate whether SEP 363856 influences the PK of a concomitantly administered OCT2 substrate, metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized, single-blind, two-period crossover study in adults with schizophrenia
| Arm | Type | Receives |
|---|---|---|
| placebo and metformin | Placebo comparator | Drug: placebo, Drug: metforminsingle dose of placebo + single dose of metformin-HCl 850 mg (approximately 663 mg metformin) (placebo will be dosed 1 hour prior to metformin administration) |
| SEP-363856 and metformin | Experimental | Drug: SEP-363856, Drug: metforminsingle dose of SEP 363856 100 mg + single dose of metformin-HCl 850 mg (SEP 363856 will be dosed 1 hour prior to metformin administration) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subject between 18 and 65 years of age, inclusive, at the time of informed consent.
- Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM 5) criteria for a primary diagnosis of schizophrenia as established by clinical interview (using the DSM 5 as a reference and confirmed using the Structured Clinical Interview for DSM 5, Clinical Trials Version [SCID CT]).
- Subject must have a Clinical Global Impressions - Severity Scale (CGI S) score ≤ 4 (normal to moderately ill) at Screening.
- Subject must have a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80 at Screening.
- Subject must have a score of ≤ 4 on the following PANSS items at Screening:
Key exclusion criteria (4 listed)
- Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study, including any clinically significant hematological (including deep vein thrombosis) or bleeding disorder, renal, metabolic, endocrine, pulmonary, gastrointestinal, urological, cardiovascular, hepatic, neurologic or allergic disease (except for untreated seasonal allergies that are asymptomatic at the time of dosing).
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 |
|---|---|---|
| placebosingle dose of placebo | Drug | placebo and metformin |
| SEP-363856single dose of SEP 363856 100 mg | Drug | SEP-363856 and metformin |
| metforminmetformin-HCl 850 mg | Drug | SEP-363856 and metformin, placebo and metformin |
Primary outcome
Area under the plasma concentration-time curve
Time frame: 72 hours
area under the plasma concentration-time curve from time zero to infinity (AUC0 ∞) or area under the plasma concentration-time curve from time zero to a defined time (AUC0-t), if appropriate
• maximum observed plasma concentration
Time frame: 72 hours
maximum observed plasma concentration (Cmax).
10 secondary outcomes
area under the plasma concentration-time curve
Time frame: 72 hours
time of the maximum observed plasma concentration
Time frame: 72 hours
time of last quantifiable concentration
Time frame: 72 hours
• percentage of extrapolated AUC0-∞
Time frame: 72 hours
terminal elimination half-life
Time frame: 72 hours
apparent clearance
Time frame: 72 hours
apparent volume of distribution
Time frame: 72 hours
amount excreted in urine
Time frame: 72 hours
percentage excreted in urine
Time frame: 72 hours
renal clearance
Time frame: 72 hours
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 26 Jun 2024.
- Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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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 SEP-363856 and metformin in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, 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 8 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 26 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
Area under the plasma concentration-time curve (time frame: 72 hours). The study lists 2 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 26 Jun 2024.