Normal, Healthy VolunteersPhase 1NCT01744808
A Study to Evaluate the Safety, Tolerance, and Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020
A Phase 1 study testing EB-1020 IR, EB-1020 SR1 and EB-1020 SR2 in people with Normal, Healthy Volunteers, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal, Healthy Volunteers
- What is being tested?
- EB-1020 IR, EB-1020 SR1 and EB-1020 SR2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Feb 2013to 1 Feb 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
- Any other condition which in the view of the Investigator is likely to interfere with study or put the subject at risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study To Investigate the Pharmacokinetics of SR Formulations; and the Food Effect, Safety, Tolerance, Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020 In Young Healthy Subjects
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.
Read the detailed description
- To investigate the safety and tolerance of single doses of EB-1020 immediate release (IR) versus three sustained release (SR) formulations.
- To investigate the safety and tolerance of a single oral dose of a SR formulation of EB-1020 in the fed and fasted state.
- To investigate the safety, tolerance, and cognitive effects of multiple oral rising doses of a SR formulation of EB-1020.
Secondary Objectives
- To characterize the single dose and steady state pharmacokinetic profiles of EB-1020 SR formulations.
- To investigate the effect of food on the pharmacokinetic profile of EB-1020 SR following single oral doses.
- Conditions
- Normal, Healthy Volunteers
- Being tested
- EB-1020 IR, EB-1020 SR1, EB-1020 SR2, EB-1020 SR3, Placebo
- Keywords
- Healthy, Normal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-1020 IRDrug
Immediate release
EB-1020 SR1Drug
sustained release
EB-1020 SR2Drug
Sustained release
EB-1020 SR3Drug
Sustained release
PlaceboOther
Placebo formulation
| Study group | Role | What they receive |
|---|---|---|
| EB-1020 SR1 | Active comparator | Sustained release formulation Receives: Drug: EB-1020 SR1 |
| EB-1020 SR2 | Active comparator | Sustained Release Formulation Receives: Drug: EB-1020 SR2 |
| EB-1020 SR3 | Active comparator | Sustained Release Formulation Receives: Drug: EB-1020 SR3 |
| EB-1020 IR | Active comparator | Immediate Release Formulation Receives: Drug: EB-1020 IR |
| Placebo | Placebo comparator | Placebo Formulation Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetic parameters
Measured: up to 6 months
Tmax
Pharmacokinetic parameter
Measured: up to 6 months
AUC
Pharmacokinetic parameter
Measured: up to 6 months
Secondary outcomes (1)
Effect of food on Cmax
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study start1 Feb 2013
- Primary completion1 Feb 2014
- Study completion1 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal, Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744808
- Sponsor's protocol ID
- EB-1020-102
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2012
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study To Investigate the Pharmacokinetics of SR Formulations; and the Food Effect, Safety, Tolerance, Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020 In Young Healthy Subjects
- ClinicalTrials.gov ID
- NCT01744808
- Acronym / sponsor ID
- EB-1020-102
- Conditions
- Normal, Healthy Volunteers
- Keywords
- Healthy, Normal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 1 Feb 2014 (actual)
- Study completion
- 1 Feb 2014 (actual)
- First posted
- 7 Dec 2012 (estimated)
- 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.
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.
Detailed description
- To investigate the safety and tolerance of single doses of EB-1020 immediate release (IR) versus three sustained release (SR) formulations.
- To investigate the safety and tolerance of a single oral dose of a SR formulation of EB-1020 in the fed and fasted state.
- To investigate the safety, tolerance, and cognitive effects of multiple oral rising doses of a SR formulation of EB-1020.
Secondary Objectives
- To characterize the single dose and steady state pharmacokinetic profiles of EB-1020 SR formulations.
- To investigate the effect of food on the pharmacokinetic profile of EB-1020 SR following single oral doses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| EB-1020 SR1 | Active comparator | Drug: EB-1020 SR1Sustained release formulation |
| EB-1020 SR2 | Active comparator | Drug: EB-1020 SR2Sustained Release Formulation |
| EB-1020 SR3 | Active comparator | Drug: EB-1020 SR3Sustained Release Formulation |
| EB-1020 IR | Active comparator | Drug: EB-1020 IRImmediate Release Formulation |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Formulation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| EB-1020 IRImmediate release | Drug | EB-1020 IR |
| EB-1020 SR1sustained release | Drug | EB-1020 SR1 |
| EB-1020 SR2Sustained release | Drug | EB-1020 SR2 |
| EB-1020 SR3Sustained release | Drug | EB-1020 SR3 |
| PlaceboPlacebo formulation | Other | Placebo |
Primary outcome
Cmax
Time frame: up to 6 months
Pharmacokinetic parameters
Tmax
Time frame: up to 6 months
Pharmacokinetic parameter
AUC
Time frame: up to 6 months
Pharmacokinetic parameter
1 secondary outcome
Effect of food on Cmax
Time frame: up to 6 months
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 13 Apr 2026.
- Otsuka Clinical Trial WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
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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 EB-1020 IR, EB-1020 SR1 and EB-1020 SR2 in people with Normal, Healthy Volunteers, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Australia.
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 7 inclusion and 16 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 13 Apr 2026. 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 Australia. 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?
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?
Cmax (time frame: up to 6 months). 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?
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 13 Apr 2026.