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

Korea Otsuka Pharmaceutical Co., Ltd.1 site in 1 country96 target enrollmentAugust 2013

ConditionsHealthy

DrugsPart1 : OPS-2071 Part1 : Placebo of OPS-2071 Part2 : OPS-2071 Part2 : Placebo of OPS-2071

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Enrollment: 96
Locations: 1
Primary Endpoint: Part2 : adverse event, body weight, physical examination, vital sign, electrocardiogram, clinical laboratory test, Bond and Lader visual analogue scale (BL VAS)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

April 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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)

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

Time Frame: 4days

Secondary Outcomes

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)
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 : Microflora test(Pre-dose, last dosing day to the day of discharge,. Day 21)