SchizophreniaPhase 1NCT03370640
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia in 2 Parts (Part 1 and 2).
A Phase 1 study testing SEP-363856 in people with Schizophrenia, run by Sumitomo Pharma Co., Ltd. at 8 sites in Japan.
Trial summary
This is a multiple oral dose, open-label study to assess the safety, tolerability, and pharmacokinetics of SEP-363856 in Japanese subjects with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SEP-363856
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 8 sitesJapan
- Study dates
- 29 Nov 2017to 20 Sep 2018
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria:The subjects who fulfill the following criteria will be included in the study.
- Subjects who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who voluntarily provide written consent to participate in the study. If the subject is considered a minor or is hospitalized involuntarily at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject.
- Japanese subject with schizophrenia between 18 to 55 years of age at the time of consent.
- Subject who has schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), diagnostic criteria, and in the opinion of the Investigator has been clinically stable.
- Subject who has body weight ≥ 40.0 kg and body mass index (BMI) ≥ 18.5 (BMI = body weight [kg] / [height (m)]2).
- Female subjects who are premenopausal and of childbearing potential must have a negative serum pregnancy test result at screening, and a negative urine pregnancy test result at clinic admission (Note: Positive urine pregnancy test will be confirmed by serum pregnancy test). Subjects who are not pregnant and are not nursing mothers.
- Female subjects who are of childbearing potential and male subjects whose partners are of childbearing potential must agree to use adequate and appropriate contraception throughout the study starting the day obtaining informed consent and for at least 30 days after the last study drug administration.
- Subjects who are able to comply with the study requirements, including physical examination, assessments, and reporting symptoms.
Exclusion Criteria:The subjects who meet any of the following criteria will be excluded from the study.
- Subject experienced an acute exacerbation of psychiatric symptoms requiring change in antipsychotic medication (with reference to drug or dose) within 3 months before screening.
- Subjects who received any sustained-release formulation (depot preparation) of antipsychotic medications within 3 months before screening.
- Subjects who received electroconvulsive therapy within 3 months before screening or is expected to require ECT during the study.
- Subjects has a history of alcohol or substance related disorders (according to DSM-5 criteria) within 6 months before screening or a positive urine drug screen at screening.
- Subjects who received other investigational products or post-marketing clinical study drugs within 3 months before screening or who have enrolled in but have not completed another clinical or post-marketing study before screening.
- Subjects with a history or complication (s) of malignant tumor within 5 years before screening, except for adequately treated basal cell or squamous cell carcinoma of skin or cervix carcinoma in situ.
- Subjects are considered by the Investigator to be affected by potent central nervous system depressants (including barbiturate).
- Subjects have previous or existing infection with HIV at screening. Subjects have a positive test for Syphilis serum reaction, Hepatitis B surface antigen or Hepatitis C antibody at screening.
- Subjects with specific suicidal ideation or those with a suicide attempt history
- Subjects have 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, etc
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Soushu Hospital
Atsugi, Kanagawa, 243-0201
Hotei Hospital
Kōnan, Aichi-ken, 483-8248
Yuge Hospital
Kumamoto, 861-8002
National Hospital Organization Hizen Psychiatric Center
Saga, 842-0192
Asakayama General Hospital
Sakai, Osaka, 590-0018
Showa University Karasuyama Hospital
Setagaya-Ku, Tokyo, 157-8577
Narimasu Kosei Hospital
tabashi City, 175-0091
Mental Support SOYOKAZE Hospital
Ueda, Nagano, 386-0401
About this study
Official title: A 2-Part Ascending Multiple Oral Dose, Open-Label Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia.
This is a multiple oral dose, open-label study to assess the safety, tolerability, and pharmacokinetics of SEP-363856 in Japanese subjects with schizophrenia.
Read the detailed description
This multicenter study will be conducted in 2 parts (Part 1 and 2). This is an ascending multiple oral dose, open-label study assessing the safety, tolerability, and pharmacokinetics of SEP-363856 in male and female subjects with schizophrenia. In part 1, subjects will have up to two visits, including a screening visit, and a 17-day in-clinic period. Eligible subjects will be admitted to the clinic on Day -4 to start or complete a taper/washout of their prior antipsychotic medication(s) under the supervision of the Investigator. On Day 1, after subjects have successfully completed the taper/washout of prior medication, subjects will be administered SEP 363856, and dosing with SEP 363856 will continue once-daily for 10 days in-clinic dosing. From Day 11 through Day 13, inclusive, subjects will be restabilized on their adequate antipsychotic medication(s) before clinic discharge on Day 14. Some subjects may require a longer restabilization process based on Investigator judgment. Subjects who discontinue the study prior to Day 13 will require an in-clinic stay for 3 days (or longer based on Investigator judgment) for restabilization on prior medications. In Part 2, Subjects will have up to two visits, including a screening visit, and a 21-day in-clinic period. Eligible subjects will be admitted to the clinic on Day -4 to start or complete a taper/washout of their prior antipsychotic medication(s) under the supervision of the Investigator. On Day 1, after subjects have successfully completed the taper/washout of prior medication, subjects will be administered SEP 363856, and dosing with SEP 363856 will continue once-daily for 14 days in-clinic dosing. From Day 15 through Day 17, inclusive, subjects will be restabilized on their adequate antipsychotic medication(s) before clinic discharge on Day 18. Some subjects may require a longer restabilization process based on Investigator judgment. Subjects who discontinue the study by Day 17 will require an in-clinic stay for 3 days (or longer based on Investigator judgment) for restabilization on prior medications.
- Conditions
- Schizophrenia
- Being tested
- SEP-363856
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEP-363856Drug
An oral 25 or 50mg dose of SEP 363856
| Study group | Role | What they receive |
|---|---|---|
| SEP-363856 Part 1 Cohort 1 | Experimental | An oral 25 mg dose of SEP 363856 once daily for 3 days, then 50 mg dose of SEP-363856 once daily for 7 days. Receives: Drug: SEP-363856 |
| SEP-363856 Part 1 Cohort 2 | Experimental | An oral 50 mg dose of SEP 363856 once daily for 3 days, then 75 mg dose of SEP-363856 once daily for 7 days. Receives: Drug: SEP-363856 |
| SEP-363856 Part 2 Cohort 3 | Experimental | An oral 25 mg dose of SEP 363856 once daily for 3 days, 50 mg dose of SEP 363856 once daily for 4 days, and then 75 mg dose of SEP-363856 once daily for 7 days. Receives: Drug: SEP-363856 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events (AEs), serious adverse events (SAEs), and AEs resulting in study discontinuation.
adverse events (AEs), serious adverse events (SAEs), and AEs resulting in study discontinuation.
Measured: Two weeks in part 1, 3 weeks in part 2.
Secondary outcomes (1)
Plasma concentrations of SEP-363856 and its metabolite SEP-363854
Plasma concentration ( Day -1 , Day 1, Day 10, and Day 11) in part 1, plasma concentration ( Day -1 , Day 1, Day 14, and Day 15) in part 2.
Measured: Twelve days in part 1, 16 days in part 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start29 Nov 2017
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370640
- Sponsor's protocol ID
- DA801004
- Other IDs
- JapicCTI-173787
- Status last verified
- Apr 2022
- First submitted
- 22 Nov 2017
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part Ascending Multiple Oral Dose, Open-Label Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia.
- ClinicalTrials.gov ID
- NCT03370640
- Acronym / sponsor ID
- DA801004
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 12 Dec 2017 (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 a multiple oral dose, open-label study to assess the safety, tolerability, and pharmacokinetics of SEP-363856 in Japanese subjects with schizophrenia.
Detailed description
This multicenter study will be conducted in 2 parts (Part 1 and 2). This is an ascending multiple oral dose, open-label study assessing the safety, tolerability, and pharmacokinetics of SEP-363856 in male and female subjects with schizophrenia. In part 1, subjects will have up to two visits, including a screening visit, and a 17-day in-clinic period. Eligible subjects will be admitted to the clinic on Day -4 to start or complete a taper/washout of their prior antipsychotic medication(s) under the supervision of the Investigator. On Day 1, after subjects have successfully completed the taper/washout of prior medication, subjects will be administered SEP 363856, and dosing with SEP 363856 will continue once-daily for 10 days in-clinic dosing. From Day 11 through Day 13, inclusive, subjects will be restabilized on their adequate antipsychotic medication(s) before clinic discharge on Day 14. Some subjects may require a longer restabilization process based on Investigator judgment. Subjects who discontinue the study prior to Day 13 will require an in-clinic stay for 3 days (or longer based on Investigator judgment) for restabilization on prior medications. In Part 2, Subjects will have up to two visits, including a screening visit, and a 21-day in-clinic period. Eligible subjects will be admitted to the clinic on Day -4 to start or complete a taper/washout of their prior antipsychotic medication(s) under the supervision of the Investigator. On Day 1, after subjects have successfully completed the taper/washout of prior medication, subjects will be administered SEP 363856, and dosing with SEP 363856 will continue once-daily for 14 days in-clinic dosing. From Day 15 through Day 17, inclusive, subjects will be restabilized on their adequate antipsychotic medication(s) before clinic discharge on Day 18. Some subjects may require a longer restabilization process based on Investigator judgment. Subjects who discontinue the study by Day 17 will require an in-clinic stay for 3 days (or longer based on Investigator judgment) for restabilization on prior medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SEP-363856 Part 1 Cohort 1 | Experimental | Drug: SEP-363856An oral 25 mg dose of SEP 363856 once daily for 3 days, then 50 mg dose of SEP-363856 once daily for 7 days. |
| SEP-363856 Part 1 Cohort 2 | Experimental | Drug: SEP-363856An oral 50 mg dose of SEP 363856 once daily for 3 days, then 75 mg dose of SEP-363856 once daily for 7 days. |
| SEP-363856 Part 2 Cohort 3 | Experimental | Drug: SEP-363856An oral 25 mg dose of SEP 363856 once daily for 3 days, 50 mg dose of SEP 363856 once daily for 4 days, and then 75 mg dose of SEP-363856 once daily for 7 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| SEP-363856An oral 25 or 50mg dose of SEP 363856 | Drug | SEP-363856 Part 1 Cohort 1, SEP-363856 Part 1 Cohort 2, SEP-363856 Part 2 Cohort 3 |
Primary outcome
Frequency of adverse events (AEs), serious adverse events (SAEs), and AEs resulting in study discontinuation.
Time frame: Two weeks in part 1, 3 weeks in part 2.
adverse events (AEs), serious adverse events (SAEs), and AEs resulting in study discontinuation.
1 secondary outcome
Plasma concentrations of SEP-363856 and its metabolite SEP-363854
Time frame: Twelve days in part 1, 16 days in part 2.
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 12 Apr 2022.
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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.
8 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 in people with Schizophrenia, run by Sumitomo Pharma Co., Ltd. at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. 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?
Frequency of adverse events (AEs), serious adverse events (SAEs), and AEs resulting in study discontinuation. (time frame: Two weeks in part 1, 3 weeks in part 2.). 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 12 Apr 2022.