A Study to Evaluate the Safety, Tolerance, and Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020

NCT01744808 | Completed Phase 1

• 1 other identifier: EB-1020-102
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether there is a food-effect with oral administration with EB-1020 as well as to obtain information on the safety, and tolerability of EB-1020 in a range of doses.

Conditions

Normal, Healthy Volunteers

Keywords

Healthy; Normal

Outcome Measures

Primary Outcomes (3)

• Cmax

  Pharmacokinetic parameters

  up to 6 months

• Tmax

  Pharmacokinetic parameter

  up to 6 months

• AUC

  Pharmacokinetic parameter

  up to 6 months

Secondary Outcomes (1)

• Effect of food on Cmax

  up to 6 months

Study Arms (5)

EB-1020 SR1

ACTIVE COMPARATOR

Sustained release formulation

Drug: EB-1020 SR1

EB-1020 SR2

ACTIVE COMPARATOR

Sustained Release Formulation

Drug: EB-1020 SR2

EB-1020 SR3

ACTIVE COMPARATOR

Sustained Release Formulation

Drug: EB-1020 SR3

EB-1020 IR

ACTIVE COMPARATOR

Immediate Release Formulation

Drug: EB-1020 IR

Placebo

PLACEBO COMPARATOR

Placebo Formulation

Other: Placebo

Interventions

Placebo OTHER

Placebo formulation

Placebo

EB-1020 SR3 DRUG

Sustained release

EB-1020 SR3

EB-1020 IR DRUG

Immediate release

EB-1020 IR

EB-1020 SR1 DRUG

sustained release

EB-1020 SR1

EB-1020 SR2 DRUG

Sustained release

EB-1020 SR2

Eligibility Criteria

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

You may qualify if:

• Aged 18-45 years inclusive
• Body weight with the normal range for height (body mass index \[BMI\] between 19-30 kg/m2 inclusive)
• If female, be of non-child bearing potential (surgically sterile, post-menopausal for 12 months or receiving a stable dose of implanted or injectable contraceptive for at least 3 months with last dose of injectable contraceptive within 2 months). Non-surgical menopause history must be confirmed by follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels as defined by established lab ranges.
• Be in general good health without clinically significant medical history
• Have clinical laboratory test results that are within the laboratory reference range; or if out of range are not clinically relevant and are acceptable to the Investigator and Sponsor medical representative
• Negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis Screening test
• Able and willing to give written informed consent

You may not qualify if:

• Receipt of any investigational agent or drug within 3 months of entry into the study
• Use of prescription drugs within 4 weeks prior to first dosing. Subjects who have used over the counter medication excluding paracetamol, topical over the counter medications and routine vitamins but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as non-clinically relevant by the Principal Investigator and Sponsor
• A history of, or current evidence for, suicidal ideation, based upon clinical interview and a psychiatric questionnaire
• A history of known or suspected seizures, spasms, infantile spasms, febrile convulsions, unexplained significant and recent loss of consciousness or history of significant head trauma with loss of consciousness or a family history (first degree relative) of epilepsy or seizures (fits)
• A history of sleep problems in the last 3 months
• A history of relevant atopy or drug hypersensitivity
• A history (within the last 5 years) or evidence of alcohol or drug abuse. Subject who consume more than 14 units (female) or 21 (male) units of alcohol a week (unit = 1 glass (125 mL) of wine = 1 measure of spirits = ½ pint of beer) will also be ineligible
• A positive urine test for drugs of abuse or alcohol at Screening or on the day of admittance to the Study Unit
• A history of smoking in the last 3 months
• Have a significant infection (such as influenza) or known inflammatory process on screening or admission
• Have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhea, heartburn )
• Have previously received EB-1020
• Be vegetarians, vegans or have medical dietary restrictions
• Any major surgical procedure within one month of entry into the study
• Have difficulties communicating reliably with the Investigator or appear unlikely to co-operate with the requirements of the study in the investigator's judgment.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

Nucleus Network Ltd.

Melbourne, Victoria, 3004, Australia

Location

Related Links

• Otsuka Clinical Trial Website
• Otsuka Clinical Trial Transparency

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: December 7, 2012
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

AU (1)