OPS-2071 Single and Multiple Dose Study to Investigate PK and PD Profile in Healthy Korean Male Subjects.

NCT ID: NCT01925521

Last Updated: 2014-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-04-30

Brief 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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Part1 : OPS-2071

Single dose, OPS-2071 30,60,120,240,300,600,900,1200mg/day

Group Type: EXPERIMENTAL

Part1 : OPS-2071

Intervention Type: DRUG

single oral dose under fasted condition

Part1 : Placebo of OPS-2071

Single dose, Placebo

Group Type: PLACEBO_COMPARATOR

Part1 : Placebo of OPS-2071

Intervention Type: DRUG

single oral dose under fasted condition

Part2 : OPS-2071

Multiple dose

Group Type: EXPERIMENTAL

Part2 : OPS-2071

Intervention Type: DRUG

multiple twice-daily oral dosing for 5-7days

Part2 : Placebo of OPS-2071

Multiple doses, Placebo

Group Type: PLACEBO_COMPARATOR

Part2 : Placebo of OPS-2071

Intervention Type: DRUG

multiple twice-daily oral dosing for 5-7days

Interventions

Part1 : OPS-2071

single oral dose under fasted condition

Intervention Type: DRUG

Part1 : Placebo of OPS-2071

single oral dose under fasted condition

Intervention Type: DRUG

Part2 : OPS-2071

multiple twice-daily oral dosing for 5-7days

Intervention Type: DRUG

Part2 : Placebo of OPS-2071

multiple twice-daily oral dosing for 5-7days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The subject is a healthy male Korean aged 21 to 45 years, inclusive.

2. The subject has a body mass index (BMI) range of 18.5 to 25.0 kg/m2, inclusive, and weighs at least 50 kg.

3. The subject provided written, informed consent prior to any clinical study-specific procedures.

4. 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.

5. Male subject must not donate sperm starting at screening and throughout the clinical study period and for 3 months after final study drug administration.

Exclusion Criteria

1. Any clinically significant history of allergic conditions

2. Any history or evidence of any clinically significant disease or as judged by the Investigator.

3. 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.

4. 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

5. 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.

6. 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).

7. 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.

8. 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.

9. Current smokers and history of smoking within 3 months prior to screening.

10. 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.

11. Any use of drugs-of-abuse within 3 months prior to the first admission to the clinical unit.

12. 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.

13. 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.

14. 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.

15. The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical study.

16. Employee of the Sponsor or the site.

17. Vulnerable subjects, e.g. subjects kept in detention.

18. Veins unsuitable for repeat venipuncture.

19. 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

InJin Jang, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

341-KOA-1301i

Identifier Type: -

Identifier Source: org_study_id