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.

Amorepacific Corporation1 site in 1 country60 target enrollmentDecember 2010

ConditionsHealthy

InterventionsPAC-14028

DrugsPAC-14028

Overview

Phase: Phase 1
Intervention: PAC-14028
Conditions: Healthy
Sponsor: Amorepacific Corporation
Enrollment: 60
Locations: 1
Primary Endpoint: Safety/Tolerability
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

June 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Amorepacific Corporation

Responsible Party

Sponsor

Eligibility Criteria

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