HealthyPhase 1OPS-2071Ph1NCT01925521
OPS-2071 Single and Multiple Dose Study to Investigate PK and PD Profile in Healthy Korean Male Subjects.
A Phase 1 study testing Part1 : OPS-2071 and Part2 : OPS-2071 in people with Healthy, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
The objective of this trial is to evaluate the safety and tolerability of single and multiple ascending oral doses of OPS-2071 in healthy male Korean Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Part1 : OPS-2071 and Part2 : OPS-2071
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Apr 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 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is a healthy male Korean aged 21 to 45 years, inclusive.
- The subject has a body mass index (BMI) range of 18.5 to 25.0 kg/m2, inclusive, and weighs at least 50 kg.
- The subject provided written, informed consent prior to any clinical study-specific procedures.
- Male subject and his female spouse/partner who is of childbearing potential must be using highly effective barrier method of contraception starting at screening and continue throughout the clinical study period and for 3 months after final study drug administration.
- Male subject must not donate sperm starting at screening and throughout the clinical study period and for 3 months after final study drug administration.
Who cannot join
- Any clinically significant history of allergic conditions
- Any history or evidence of any clinically significant disease or as judged by the Investigator.
- Any clinically significant abnormality after the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or admission to the clinical unit.
- A mean pulse of <45 or >90 beats per minute (bpm) and mean systolic blood pressure (SBP) >140 mmHg; mean diastolic blood pressure (DBP) >90 mmHg
- A mean QTcB interval >450 ms at screening. If the mean QTcB exceeds the limits above, one additional triplicate ECG may be taken. If this triplicate also gives an abnormal result, the subject should be excluded.
- Use of any prescribed or non-prescribed drugs in the 2 weeks prior to study drug administration, except for the occasional use of paracetamol (up to 2 g/day).
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- Consumption of grapefruit, pomelo, citrus fruits, starfruit, pomegranate, papaya, mango, rambutan, kiwi fruit, dragon fruit or passion fruit and products containing these fruits in the 2 weeks prior to study drug administration.
- Excessive use of caffeine-containing beverages exceeding 500 mg caffeine/day (5 cups of coffee) and the inability to refrain from the use of caffeine-containing beverages during confinement in the clinical unit.
- Current smokers and history of smoking within 3 months prior to screening.
- History of drinking more than 21 units of alcohol per week (1 unit=10 g pure alcohol=250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) within 3 months prior to the first admission to the clinical unit.
- Any use of drugs-of-abuse within 3 months prior to the first admission to the clinical unit.
- Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days, or donated plasma within 7 days prior to the first admission to the clinical unit.
- Positive serology test for hepatitis B surface antigen, hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) 1 and/or 2 antibodies.
- Participation in any clinical study within 3 months prior to the expected date of enrolment into the clinical study, provided that the clinical study did not entail a biological compound with a longer t½ or participation in more than 3 clinical studies within 12 months.
- The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical study.
- Employee of the Sponsor or the site.
- Vulnerable subjects, e.g. subjects kept in detention.
- Veins unsuitable for repeat venipuncture.
- Are unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g. uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A phase1,Randomized,Double-blind,Placebo-controlled,Two-part,Sequential Ascending Single and Multiple Dose Study to Investigate the Safety, Tolerability and the PK and PD Profile of OPS-2071 in Healthy Male Korean Subjects
The objective of this trial is to evaluate the safety and tolerability of single and multiple ascending oral doses of OPS-2071 in healthy male Korean
- Conditions
- Healthy
- Being tested
- Part1 : OPS-2071, Part1 : Placebo of OPS-2071, Part2 : OPS-2071, Part2 : Placebo of OPS-2071
- Keywords
- Intestinal Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part1 : OPS-2071Drug
single oral dose under fasted condition
Part1 : Placebo of OPS-2071Drug
single oral dose under fasted condition
Part2 : OPS-2071Drug
multiple twice-daily oral dosing for 5-7days
Part2 : Placebo of OPS-2071Drug
multiple twice-daily oral dosing for 5-7days
| Study group | Role | What they receive |
|---|---|---|
| Part1 : OPS-2071 | Experimental | Single dose, OPS-2071 30,60,120,240,300,600,900,1200mg/day Receives: Drug: Part1 : OPS-2071 |
| Part1 : Placebo of OPS-2071 | Placebo comparator | Single dose, Placebo Receives: Drug: Part1 : Placebo of OPS-2071 |
| Part2 : OPS-2071 | Experimental | Multiple dose Receives: Drug: Part2 : OPS-2071 |
| Part2 : Placebo of OPS-2071 | Placebo comparator | Multiple doses, Placebo Receives: Drug: Part2 : Placebo of OPS-2071 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part1 : adverse event, body weight, physical examination, vital sign, electrocardiogram, clinical laboratory test
Measured: 4days
Part2 : adverse event, body weight, physical examination, vital sign, electrocardiogram, clinical laboratory test, Bond and Lader visual analogue scale (BL VAS)
Bond and Lader VAS: Day -1 and last dosing day (within 1 hour of expected Cmax)
Measured: 21days
Secondary outcomes (6)
Part1 : Plasma pharmacokinetic parameters of OPS-2071
Cmax, tmax, AUC and so on.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Part2 : Plasma Pharmacokinetic parameters of OPS-2071
Cmax, tmax, AUCtau, C12 and so on.
Measured: Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-morning-dose , Days 2 to 6: pre morning and evening dose, last dosing day: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose.
Part1 : Urine Pharmacokinetic parameter of OPS-2071
Measured: Day 1: pre-dose, 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours post-dose
Part2 : Urine pharmacokinetic parameter of OPS-2071
Measured: Day 1 and last dosing day : pre-morning dose, 0-4 post-morning dose, 4-8 post-morning dose and 8-12 hours post-morning dose.
Part1 : Fecal pharmacokinetic parameters of OPS-2071
Feces sample is collected in the 120-mg group only: All post-dose samples will be collected until discharge. Actual sampling time point will be recorded.
Measured: All post-dose samples
Part2 : Microflora test
Measured: Pre-dose, last dosing day to the day of discharge,. Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- InJin Jang, M.D.,Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925521
- Sponsor's protocol ID
- 341-KOA-1301i
- Acronym
- OPS-2071Ph1
- Status last verified
- Nov 2014
- First submitted
- 12 Aug 2013
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A phase1,Randomized,Double-blind,Placebo-controlled,Two-part,Sequential Ascending Single and Multiple Dose Study to Investigate the Safety, Tolerability and the PK and PD Profile of OPS-2071 in Healthy Male Korean Subjects
- ClinicalTrials.gov ID
- NCT01925521
- Acronym / sponsor ID
- OPS-2071Ph1 / 341-KOA-1301i
- Conditions
- Healthy
- Keywords
- Intestinal Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Aug 2013 (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.
The objective of this trial is to evaluate the safety and tolerability of single and multiple ascending oral doses of OPS-2071 in healthy male Korean
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part1 : OPS-2071 | Experimental | Drug: Part1 : OPS-2071Single dose, OPS-2071 30,60,120,240,300,600,900,1200mg/day |
| Part1 : Placebo of OPS-2071 | Placebo comparator | Drug: Part1 : Placebo of OPS-2071Single dose, Placebo |
| Part2 : OPS-2071 | Experimental | Drug: Part2 : OPS-2071Multiple dose |
| Part2 : Placebo of OPS-2071 | Placebo comparator | Drug: Part2 : Placebo of OPS-2071Multiple doses, Placebo |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject is a healthy male Korean aged 21 to 45 years, inclusive.
- The subject has a body mass index (BMI) range of 18.5 to 25.0 kg/m2, inclusive, and weighs at least 50 kg.
- The subject provided written, informed consent prior to any clinical study-specific procedures.
- Male subject and his female spouse/partner who is of childbearing potential must be using highly effective barrier method of contraception starting at screening and continue throughout the clinical study period and for 3 months after final study drug administration.
- Male subject must not donate sperm starting at screening and throughout the clinical study period and for 3 months after final study drug administration.
Key exclusion criteria (19 listed)
- Any clinically significant history of allergic conditions
- Any history or evidence of any clinically significant disease or as judged by the Investigator.
- Any clinically significant abnormality after the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or admission to the clinical unit.
- A mean pulse of <45 or >90 beats per minute (bpm) and mean systolic blood pressure (SBP) >140 mmHg; mean diastolic blood pressure (DBP) >90 mmHg
- A mean QTcB interval >450 ms at screening. If the mean QTcB exceeds the limits above, one additional triplicate ECG may be taken. If this triplicate also gives an abnormal result, the subject should be excluded.
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 |
|---|---|---|
| Part1 : OPS-2071single oral dose under fasted condition | Drug | Part1 : OPS-2071 |
| Part1 : Placebo of OPS-2071single oral dose under fasted condition | Drug | Part1 : Placebo of OPS-2071 |
| Part2 : OPS-2071multiple twice-daily oral dosing for 5-7days | Drug | Part2 : OPS-2071 |
| Part2 : Placebo of OPS-2071multiple twice-daily oral dosing for 5-7days | Drug | Part2 : Placebo of OPS-2071 |
Primary outcome
Part1 : adverse event, body weight, physical examination, vital sign, electrocardiogram, clinical laboratory test
Time frame: 4days
Part2 : adverse event, body weight, physical examination, vital sign, electrocardiogram, clinical laboratory test, Bond and Lader visual analogue scale (BL VAS)
Time frame: 21days
Bond and Lader VAS: Day -1 and last dosing day (within 1 hour of expected Cmax)
6 secondary outcomes
Part1 : Plasma pharmacokinetic parameters of OPS-2071
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
Part2 : Plasma Pharmacokinetic parameters of OPS-2071
Time frame: Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-morning-dose , Days 2 to 6: pre morning and evening dose, last dosing day: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose.
Part1 : Urine Pharmacokinetic parameter of OPS-2071
Time frame: Day 1: pre-dose, 0-4, 4-8, 8-12, 12-24, 24-48 and 48-72 hours post-dose
Part2 : Urine pharmacokinetic parameter of OPS-2071
Time frame: Day 1 and last dosing day : pre-morning dose, 0-4 post-morning dose, 4-8 post-morning dose and 8-12 hours post-morning dose.
Part1 : Fecal pharmacokinetic parameters of OPS-2071
Time frame: All post-dose samples
Part2 : Microflora test
Time frame: Pre-dose, last dosing day to the day of discharge,. Day 21
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 7 Nov 2014.
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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.
InJin Jang, M.D.,Ph.D. principal investigator
Seoul National University Hospital
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 Part1 : OPS-2071 and Part2 : OPS-2071 in people with Healthy, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 5 inclusion and 19 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 7 Nov 2014. 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 South Korea. 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?
Part1 : adverse event, body weight, physical examination, vital sign, electrocardiogram, clinical laboratory test (time frame: 4days). The study lists 2 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 7 Nov 2014.