SchizophreniaPhase 1NCT03627195

A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia

A Phase 1 study testing DSP-1349M in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A study to determine the maximum tolerated dose of an investigational drug in subjects with schizophrenia Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: DSP-1349M
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 7 Jun 2018to 29 Mar 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

1. Subject has capacity; is willing and able to provide written consent for use and disclosure of protected health information per requirements of 45CFR164.508 (Health Insurance Portability and Accountability Act; HIPAA) prior to initiating any study procedure after being informed of the nature of the study, in the opinion of the study staff and PI.
2. Subject is male or female 18 to 65 years of age, inclusive. 3. Subject has a diagnosis of schizophrenia as per DSM-IV-TR criteria, which in the opinion of the Investigator has been clinically stable for the past 6 months.
4. Subject has a Body Mass Index (BMI) greater than or equal to 19.5 and less than or equal to 38 kg/m2.
5. Subject does not have clinically relevant abnormal laboratory values per Investigator discretion.
6. Subject does not have clinically relevant findings from vital signs measurements per Investigator discretion.
7. Female subject is eligible to enter and participate in the study if she is of:

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Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal);
Postmenopausal females defined as being amenorrheic for greater than 2 years (or confirmed by FSH level) with an appropriate clinical profile.
Women who have not been confirmed as postmenopausal should be advised to use contraception as outlined below.
Women who have had a hysterectomy, bilateral oophorectomy or bilateral salpingectomy (as determined by subject's medical history).
Child-bearing potential (all females ≤ 65 years of age), has a negative pregnancy test at screening and agrees to satisfy one of the following requirements:
Complete abstinence from intercourse (as part of an abstinent lifestyle) a minimum of 2 months prior to administration of the first dose of study drug, throughout the Treatment Period, and for a minimum of 3 months after completion or premature discontinuation from the study drug; or,
Established use of highly effective methods of contraception from 1 month prior to administration of the first dose of study drug, during the Treatment Period, and 60 days after completion or premature discontinuation from the study drug.
Because of the unacceptable failure rate of barrier (chemical and/or physical) methods, the barrier method of contraception must only be used in combination with a highly effective method. Post-coital methods of contraception are not permitted.
8. Male subjects with partners of child bearing potential must be practicing abstinence, part of an abstinent life style or using protocol-specified methods of birth control throughout the study and for 30 days after completion or premature discontinuation from the study drug.
9. Subject is able and willing to remain off of prior antipsychotic medication until the protocol-specified restabilization period.
10. Subject has a stable living arrangement for at least 3 months prior to Day -12 and agrees to return to a similar living arrangement after discharge. Such subjects remain eligible to participate in this protocol with approval from the PI. Chronically homeless subjects should not be enrolled. The Medical Monitor should be consulted for individual cases as

Who cannot join

Subject had an acute exacerbation of psychiatric symptoms requiring change in antipsychotic medication (with reference to drug or dose) within 3 months (90 days) before screening.
Subject has known or suspected carcinoma.
Subject has known presence or history of renal or hepatic insufficiency.
Subject has significant disease(s) or clinically significant finding(s) on physical examination determined by the Investigator to pose a health concern to the subject while on study.
Subject has a history or presence of clinically significant abnormal ECG (based on ECG central overread report) that may jeopardize the subject's safety to participate in this study, or a screening 12-lead ECG demonstrating any one of the following: heart rate (HR) > 100 bpm, QRS > 120 msec, QTcF > 450 msec, or PR > 220 msec.
Subject has known history of a severe reaction to a previous antipsychotic (in the Investigator's opinion), including up to 80 mg/day of oral lurasidone.

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Subject has a history of drug-dependence as per DSM-IV-TR criteria during the six month period immediately prior to study entry.
Subject has known or suspected excessive alcohol consumption, (exceeding more than 4 drinks on any single day or more than 14 drinks per week; 1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of the screening visit or a positive urine alcohol test at screening.
Subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the C-SSRS at screening (in the past 1 month [30 days]) or at any point prior to randomization or history of suicidal behavior within the last two years.
Subject has significant orthostatic hypotension at screening (ie, 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).
Subject has presence or history (within the last year) of a medical or surgical condition that might interfere with the absorption, metabolism, or excretion of administered Lurasidone injectable suspension.
Subject has a history of epilepsy or risk of having seizures.
Subject has a positive urine alcohol at screening or on Day -12.
Subject has positive test results within 28 days prior to the start of the study for:
Human immunodeficiency virus (HIV).
Hepatitis B surface antigen and Hepatitis C antibody.
Urine drug test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines, methadone, or other drugs of abuse). However, a positive test for benzodiazepines may not result in exclusion of subjects if the Investigator determines that the use of a prescription benzodiazepine is appropriate.
Serum β-human chorionic gonadotropin (HCG) consistent with pregnancy (females only).
Subject has used of any inhibitor or inducer of CYP3A4 taken within 28 days prior to drug administration and until discharge.
Subject has have used of concomitant medications that prolong the QT/QTc interval within 28 days prior to Day -12 through follow-up.
Subject has received depot neuroleptics unless the last injection was at least one treatment cycle before Day -12.
Subject has poor peripheral venous access or does not tolerate venipuncture that would cause difficulty for collecting blood samples.
Subject has experienced significant blood loss (≥ 473 mL) or donated blood within 30 days prior to screening, or intends to donate plasma or blood or undergo elective surgery during study participation or within 30 days after the last study visit.
Subject has a prolactin concentration greater than or equal to 200 ng/mL at screening.
Subject is unwilling to abstain from vigorous exercise from Day -12 until study discharge.
Subjects has a significant risk of violent behavior or a significant risk of suicidal behavior based on history or in the PI's judgment OR is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
Subject has a history of allergic reaction (clinically relevant history of drug hypersensitivity) or has a known or suspected sensitivity to any substance that is contained in the study drug or to Polysorbate 80, sodium chloride, or sodium phosphate.
Subject requires treatment with a drug that consistently prolongs the QTc interval.
Subject is currently participating, or has participated in a study with an investigational or marketed compound or device within 30 days prior to signing the informed consent, or Protocol D1052024, Version 2.00 Lurasidone Injectable Suspension Confidential and Proprietary 36 13 June 2018 has participated in 3 or more studies within 18 months prior to signing the informed consent.
Subject is a staff member or the relative of a staff member.
Subject, in the Investigator's opinion, is unsuitable in any other way to participate in the study.
Subject is unable or unwilling to comply with study instructions, procedures or restrictions.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dr. David Walling
Long Beach, California, 90806

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Placebo Controlled, Single Ascending Dose Study With Lurasidone Injectable Suspension to Evaluate Safety, Tolerability and Pharmacokinetics in Subjects With Schizophrenia

A study to determine the maximum tolerated dose of an investigational drug in subjects with schizophrenia

Read the detailed description

This is a single-center, randomized, double-blind, placebo-controlled, inpatient, single ascending dose (SAD) study designed to evaluate the safety, tolerability, and PK of lurasidone injectable suspension in subjects with schizophrenia. This study will determine the minimum intolerable dose (MID), the maximum tolerated dose (MTD) of lurasidone injectable suspension, and characterize the PK profiles of lurasidone and its metabolites in serum (ID-14283, ID-14326, ID-11614, ID-20219, and ID-20220) and urine (ID-14283, ID-14326, and ID-11614) in this subject population. The potential effects of gender on the PK of lurasidone injectable suspension and its metabolites will also be evaluated when applicable.

Conditions: Schizophrenia
Being tested: DSP-1349M, placebo
Keywords: Schizophrenia
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DSP-1349MDrug
Also called lurasidone
DSP-1349M injectable
placeboDrug
placebo injection

Study groups in NCT03627195
Study group	Role	What they receive
DSP-1349M	Experimental	Lurasidone injection suspension (30 mg, 75 mg, 150 mg, 300 mg, and 450 mg) Receives: Drug: DSP-1349M
Placbo	Placebo comparator	placebo injection Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs ) Leading to Study Discontinuation
Number of subjects with any Adverse Events (AEs), serious adverse events (SAEs), and Adverse Events (AEs ) leading to study discontinuation
Measured: Day 61
Maximum Serum Concentration [Cmax] for Lurasidone After Lurasidone Injectable Suspension Administration
The maximum Serum Concentration [Cmax] for lurasidone after lurasidone injectable suspension administration
Measured: Day 61
Area Under the Curve From Time 0 to Time of Last Quantifiable Concentration [AUC0-last] for Lurasidone After Lurasidone Injectable Suspension Administration
The area Under the Curve from time 0 to time of last quantifiable concentration [AUC0-last] for lurasidone after lurasidone injectable suspension administration
Measured: Day 61

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 201829 Mar 2019

First posted13 Aug 2018
Study start7 Jun 2018
Primary completion29 Mar 2019
Study completion29 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03627195
Sponsor's protocol ID: D1052024
Status last verified: Apr 2020
First submitted: 7 Aug 2018
Last updated: 8 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo Controlled, Single Ascending Dose Study With Lurasidone Injectable Suspension to Evaluate Safety, Tolerability and Pharmacokinetics in Subjects With Schizophrenia
ClinicalTrials.gov ID: NCT03627195
Acronym / sponsor ID: D1052024
Conditions: Schizophrenia
Keywords: Schizophrenia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: 7 Jun 2018 (actual)
Primary completion: 29 Mar 2019 (actual)
Study completion: 29 Mar 2019 (actual)
First posted: 13 Aug 2018 (actual)
Results: Posted 8 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A study to determine the maximum tolerated dose of an investigational drug in subjects with schizophrenia

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
DSP-1349M	Experimental	Drug: DSP-1349MLurasidone injection suspension (30 mg, 75 mg, 150 mg, 300 mg, and 450 mg)
Placbo	Placebo comparator	Drug: placeboplacebo injection

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

1. Subject has capacity; is willing and able to provide written consent for use and disclosure of protected health information per requirements of 45CFR164.508 (Health Insurance Portability and Accountability Act; HIPAA) prior to initiating any study procedure after being informed of the nature of the study, in the opinion of the study staff and PI.
2. Subject is male or female 18 to 65 years of age, inclusive. 3. Subject has a diagnosis of schizophrenia as per DSM-IV-TR criteria, which in the opinion of the Investigator has been clinically stable for the past 6 months.
4. Subject has a Body Mass Index (BMI) greater than or equal to 19.5 and less than or equal to 38 kg/m2.
5. Subject does not have clinically relevant abnormal laboratory values per Investigator discretion.
6. Subject does not have clinically relevant findings from vital signs measurements per Investigator discretion.

Key exclusion criteria (32 listed)

Subject had an acute exacerbation of psychiatric symptoms requiring change in antipsychotic medication (with reference to drug or dose) within 3 months (90 days) before screening.
Subject has known or suspected carcinoma.
Subject has known presence or history of renal or hepatic insufficiency.
Subject has significant disease(s) or clinically significant finding(s) on physical examination determined by the Investigator to pose a health concern to the subject while on study.
Subject has a history or presence of clinically significant abnormal ECG (based on ECG central overread report) that may jeopardize the subject's safety to participate in this study, or a screening 12-lead ECG demonstrating any one of the following: heart rate (HR) > 100 bpm, QRS > 120 msec, QTcF > 450 msec, or PR > 220 msec.

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
DSP-1349MAlso: lurasidoneDSP-1349M injectable	Drug	DSP-1349M
placeboplacebo injection	Drug	Placbo

Primary outcome

Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs ) Leading to Study Discontinuation
Time frame: Day 61
Number of subjects with any Adverse Events (AEs), serious adverse events (SAEs), and Adverse Events (AEs ) leading to study discontinuation
Maximum Serum Concentration [Cmax] for Lurasidone After Lurasidone Injectable Suspension Administration
Time frame: Day 61
The maximum Serum Concentration [Cmax] for lurasidone after lurasidone injectable suspension administration
Area Under the Curve From Time 0 to Time of Last Quantifiable Concentration [AUC0-last] for Lurasidone After Lurasidone Injectable Suspension Administration
Time frame: Day 61
The area Under the Curve from time 0 to time of last quantifiable concentration [AUC0-last] for lurasidone after lurasidone injectable suspension administration

Results and safety

Results posted to the registry on 8 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lurasidone 30 mg	6	5
Lurasidone 75 mg	6	6
Lurasidone 150 mg	6	6
Lurasidone 300 mg	6	6
Lurasidone 450 mg	6	6
Placebo	10	10

Primary outcome: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs ) Leading to Study Discontinuation

Time frame: Day 61. Number. Unit: count of participants

Measure	Lurasidone 30 mg n = 6	Lurasidone 75 mg n = 6	Lurasidone 150 mg n = 6	Lurasidone 300 mg n = 6	Lurasidone 450 mg n = 6	Placebo n = 10
Incidence of AEs	4	4	2	4	5	5
Incidence of SAEs	0	0	0	0	0	0
Incidence of AEs leading to study discontinuation	0	0	0	0	0	0

Primary outcome: Maximum Serum Concentration [Cmax] for Lurasidone After Lurasidone Injectable Suspension Administration

Time frame: Day 61. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Lurasidone 30 mg n = 6	Lurasidone 75 mg n = 5	Lurasidone 150 mg n = 6	Lurasidone 300 mg n = 6	Lurasidone 450 mg n = 6	Placebo n = 10
Value	1.08 (65.6)	3.90 (51.6)	5.08 (46.5)	8.85 (62.8)	9.50 (48.3)	0 (0)

Population analysed: Pharmacokinetic Population

Primary outcome: Area Under the Curve From Time 0 to Time of Last Quantifiable Concentration [AUC0-last] for Lurasidone After Lurasidone Injectable Suspension Administration

Time frame: Day 61. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Lurasidone 30 mg n = 6	Lurasidone 75 mg n = 5	Lurasidone 150 mg n = 6	Lurasidone 300 mg n = 6	Lurasidone 450 mg n = 6	Placebo n = 10
Value	628 (54.7)	2000 (6.6)	3540 (26.0)	4910 (47.9)	7490 (32.6)	0 (0)

Population analysed: Pharmacokinetic Population

Adverse events

Time frame: 61 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lurasidone 30 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Lurasidone 75 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Lurasidone 150 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Lurasidone 300 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Lurasidone 450 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Placebo	0 of 10 (0%)	5 of 10 (50%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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 DSP-1349M 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 17 inclusion and 32 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 May 2020. 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. 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?

Yes. Results are posted in the registry (first posted 8 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs ) Leading to Study Discontinuation (time frame: Day 61). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03627195.

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 May 2020.