PAC-14028 in Healthy Male Volunteers

Study Overview
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Brief Summary
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Primary Objective: To evaluate safety and tolerability of single and multiple oral dosing of PAC-14028 in healthy male volunteers. Secondary Objective: To evaluate pharmacokinetics and pharmacodynamics of single and multiple oral dosing of PAC-14028 in healthy male volunteers.

Official Title
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A Dose-block Randomized, Double-blind, Placebo-controlled Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of PAC-14028 After Oral Administration in Healthy Male Volunteers.

Conditions
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Healthy

Intervention / Treatment
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* Drug: PAC-14028


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men aged 20 to 45 years at the time of screening Whose weight is 50kg or more, but less than 90 kg, and whose body mass index(BMI) is 19.0 kg/m^2 or more but less than 27 kg/m^2 -BMI (kg/m^2) = weight(kg) /{height(m)}^2 Who voluntarily decides study participation after receiving detailed explanation about the study and fully understanding it and who provides written consent for compliance with study requirement including proper contraception. Exclusion Criteria: Who has clinically significant medical history or diseases involving liver, kidney, neurological system, respiratory system, endocrine system, urinary system, cardiovascular system, psychical disorders or blood tumor Who has gastrointestinal diseases or operation history which may interfere study drug absorption (however, except simple appendectomy and hernioplasty ) Who has a history of hypersensitivity or allergies to any drug (aspirin, antibiotics, etc) Who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.) Who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine) Smoker or who has stopped smoking within previous 1 month or shows positive result at cotinine test. Who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody) Who consistently consumes alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol) Who has participated in other clinical study within 12 weeks before study drug administration (however, the last dosing day is considered as the end of clinical study.) Who has had bleeding or blood collection and donation over 400 mL within 12 weeks before study drug administration Whose vital sign measured at sitting position after resting at least 5 minutes is as following Low blood pressure (Systolic pressure: 90 mmHg or less, Diastolic pressure: 50 mmHg or less) High blood pressure (Systolic pressure: 140 mmHg or higher, Diastolic pressure: 90 mmHg or less) Who is determined ineligible for study participation by investigators for any reason including clinical lab test and ECG results.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAC-14028<br> | Drug: PAC-14028<br>* tablets, oral administration, single/multiple dosing, dose escalation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/Tolerability | AE incidence pattern, abnormal findings in vital sign, ECG test, and clinical lab tests |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics/dynamics | PK:Concentration of PAC-14028 in Blood and Urine; Cmax, AUC PD:Heat pain threshold/tolerance |  |