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

NCT01925521 | Completed Phase 1 DMC

• 1 other identifier: 341-KOA-1301i
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

Intestinal Infection

Outcome Measures

Primary Outcomes (2)

• Part1 : adverse event, body weight, physical examination, vital sign, electrocardiogram, clinical laboratory test

  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)

  21days

Secondary Outcomes (6)

• Part1 : Plasma pharmacokinetic parameters of OPS-2071

  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

  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

  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

  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

  All post-dose samples

Study Arms (4)

Part1 : OPS-2071

EXPERIMENTAL

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

Drug: Part1 : OPS-2071

Part1 : Placebo of OPS-2071

PLACEBO COMPARATOR

Single dose, Placebo

Drug: Part1 : Placebo of OPS-2071

Part2 : OPS-2071

EXPERIMENTAL

Multiple dose

Drug: Part2 : OPS-2071

Part2 : Placebo of OPS-2071

PLACEBO COMPARATOR

Multiple doses, Placebo

Drug: Part2 : Placebo of OPS-2071

Interventions

Part1 : OPS-2071 DRUG

single oral dose under fasted condition

Part1 : OPS-2071

Part1 : Placebo of OPS-2071 DRUG

single oral dose under fasted condition

Part1 : Placebo of OPS-2071

Part2 : OPS-2071 DRUG

multiple twice-daily oral dosing for 5-7days

Part2 : OPS-2071

Part2 : Placebo of OPS-2071 DRUG

multiple twice-daily oral dosing for 5-7days

Part2 : Placebo of OPS-2071

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• InJin Jang, M.D.,Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 19, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 7, 2014

Record last verified: 2014-11

Locations

KR (1)