Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics

NCT01972711 | Completed Phase 1

• 1 other identifier: SEP361-104
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy male and female volunteers with high or low schizotype characteristics.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• BOLD fMRI activity in key regions of interest (ROIs) while performing the Monetary Incentive Delay (MID), N-back, and Signal detection (SD) tasks after a single-dose of study medication

  Up to 6 Weeks

Secondary Outcomes (3)

• Behavioural performance in the MID task, includes measurements of trial accuracy, trial duration, trial reaction time and amount of money won.

  Up to 6 Weeks

• Behavioural performance in the N-back task, includes measurements of accuracy (% correct for each trial type), reaction time and target sensitivity (d').

  Up to 6 Weeks

• Behavioural performance in the SD task, includes measurements of correct and incorrect responses.

  Up to 6 Weeks

Study Arms (3)

SEP-363856

EXPERIMENTAL

Single-dose SEP-363856 50 mg

Drug: SEP-363856

Amisulpride

ACTIVE COMPARATOR

Single-dose Amisulpride 400 mg.

Drug: Amisulpride

Placebo

PLACEBO COMPARATOR

Matched placebo

Drug: Placebo

Interventions

SEP-363856 DRUG

SEP-36385625 as a single oral dose of 50 mg

SEP-363856

Amisulpride DRUG

Amisulpride as a single oral dose of 400 mg

Amisulpride

Placebo DRUG

single oral dose placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged 18 to 45 years, inclusive, at Day 1.
• Subject must be healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring within four weeks of randomisation. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• Subject must be normotensive with sitting (5 minutes) blood pressure between the range of 90 to 150 mm Hg systolic, inclusive, and 60 to 90 mm Hg diastolic, inclusive, at Screening.
• Subject must have sitting (5 minutes) heart rate ≥ 50 beats per minute at Screening.
• Subject must agree to use one of the following birth control/contraception methods from Screening until 90 days after receiving study drug.
• Female subject of child bearing potential (≤ 65 years) should be surgically sterile or abstinent or, if sexually active, must use an adequate method of contraception in addition to their partner(s) using a barrier method.
• Male subject with female partner(s) of childbearing potential must take appropriate precautions to avoid fathering a child and use barrier contraception, in addition to their female partner(s) using another method.
• Male subject must not donate sperm.
• Acceptable forms of contraception are as follows:
• Barrier methods: condoms, diaphragms, cervical caps; with a spermicide foam, gel, film, cream or pessary.
• Non-hormone containing intrauterine methods: intrauterine devices or systems.
• Other: prescription oral contraceptives, contraceptive injections, contraceptive implant, contraceptive vaginal ring, hormonal intrauterine device, double-barrier method, contraceptive patch, or male partner sterilisation.
• Subject must have normal ECG results, including QTcF \< 450msec (for men) or \< 470 ms (for women) (based on the Fridericia correction where QTcF = QT/RR0.33) at Screening.
• Subject must be a completely fluent English speaker who, in the opinion of the Investigator, is capable of completing the fMRI and behavioural tasks.
• Subject must be right-handed.

You may not qualify if:

• Subject with a history of alcohol or substance dependence within the last 12 months from Screening.
• Subject with a positive urine drug screen at Screening or Day 1. One re-test within 1 to 3 days is permitted if positive result is believed to be due to licenced opiate-based medication or ingestion of poppy seeds. In this event, re-test result will be used for assessing entry criterion and must be completed prior to randomisation.
• Subject with a positive alcohol breath test at Screening or Day 1.
• Female subject with a positive pregnancy test at Screening or Day 1.
• Female subject currently pregnant or trying to get pregnant or currently breast feeding.
• Subject who consumes large amounts of caffeinated drinks (more than 8 cups of standard caffeinated drinks (tea, instant coffee) or 6 cups of stronger coffee or other drinks containing methylxanthines such as coca cola or Red Bull per day).
• Subject with a relevant history, or presence upon clinical examination, of cardiac, ophthalmologic, pulmonary, endocrine (diabetes), blood disease, gastro-intestinal, hepatic or renal disease or other condition which in the opinion of the Investigator could interfere with the test procedures.
• Subject with a history of cancer, except for basal cell or Stage 1 squamous cell carcinoma of the skin which has been in remission for at least 5 years prior to Day 1.
• Subject meets the diagnostic criteria for schizophrenia, or any other psychotic disorder, as determined by the SCID-I at Screening
• Subject with a history of, or presents (in the opinion of the Investigator) with, significant neurological or psychiatric conditions (such as stroke, traumatic brain injury, depression, seizures, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, blackouts requiring hospitalisation).
• Subject with a history of positive HIV test.
• Subject with a history of, or current condition of, migraine headaches or has undergone operations to the head.
• Subject with a significant hearing impairment which, in the opinion of the Investigator, may interfere with the performance of the behavioural tasks or fMRI tasks.
• Subject with a significant visual impairment including colour blindness, or history of ocular treatment including corrective laser eye surgery, or ongoing condition, which in the opinion of the Investigator may interfere with the performance of the behavioural tasks or fMRI tasks.
• Subject received prescribed medication within 28 days prior to Day 1 (apart from the contraceptive pill). Subjects who have taken prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety (see Section 10.2, Concomitant Medications).

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (2)

Department of Psychiatry, University of Oxford, Warneford Hospital

Headington, Oxford, OX3 7JX, United Kingdom

Location

University of Manchester, Neuroscience and Psychiatry Unit

Manchester, M13 9PT, United Kingdom

Location

Related Publications (1)

• Perini F, Nazimek JM, Mckie S, Capitao LP, Scaife J, Pal D, Browning M, Dawson GR, Nishikawa H, Campbell U, Hopkins SC, Loebel A, Elliott R, Harmer CJ, Deakin B, Koblan KS. Effects of ulotaront on brain circuits of reward, working memory, and emotion processing in healthy volunteers with high or low schizotypy. Schizophrenia (Heidelb). 2023 Aug 7;9(1):49. doi: 10.1038/s41537-023-00385-6.

  PMID: 37550314 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856; Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

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

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: October 30, 2013
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

GB (2)