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

NCT03627195 | Completed Phase 1 Results FDA Drug

• 1 other identifier: D1052024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Day 61

Study Arms (2)

DSP-1349M

EXPERIMENTAL

Lurasidone injection suspension (30 mg, 75 mg, 150 mg, 300 mg, and 450 mg)

Drug: DSP-1349M

Placbo

PLACEBO COMPARATOR

placebo injection

Drug: placebo

Interventions

DSP-1349M DRUG

DSP-1349M injectable

Also known as: lurasidone

DSP-1349M

placebo DRUG

placebo injection

Placbo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. Subject has a Body Mass Index (BMI) greater than or equal to 19.5 and less than or equal to 38 kg/m2.
• \. Subject does not have clinically relevant abnormal laboratory values per Investigator discretion.
• \. Subject does not have clinically relevant findings from vital signs measurements per Investigator discretion.
• \. Female subject is eligible to enter and participate in the study if she is of:
• a. 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).
• b. 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.
• \. 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (1)

Dr. David Walling

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals, Inc.

ClinicalTrialDisclosure@sunovion.com

1-866-503-6351

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 13, 2018
• Study Start: June 7, 2018
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: May 8, 2020
• Results First Posted: May 8, 2020

Record last verified: 2020-04

Locations

US (1)