Clinical trial NCT01264224: PAC-14028 in Healthy Male Volunteers
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 1. Primary Objective:

   * To evaluate safety and tolerability of single and multiple oral dosing of PAC-14028 in healthy male volunteers.
2. Secondary Objective:

   * To evaluate pharmacokinetics and pharmacodynamics of single and multiple oral dosing of PAC-14028 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

1. Healthy men aged 20 to 45 years at the time of screening
2. 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
3. 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:

1. 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
2. Who has gastrointestinal diseases or operation history which may interfere study drug absorption (however, except simple appendectomy and hernioplasty )
3. Who has a history of hypersensitivity or allergies to any drug (aspirin, antibiotics, etc)
4. 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.)
5. Who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine)
6. Smoker or who has stopped smoking within previous 1 month or shows positive result at cotinine test.
7. Who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)
8. Who consistently consumes alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol)
9. 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.)
10. Who has had bleeding or blood collection and donation over 400 mL within 12 weeks before study drug administration
11. 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)
12. Who is determined ineligible for study participation by investigators for any reason including clinical lab test and ECG results.

Primary outcomes:
measure: Safety/Tolerability
Secondary outcomes:
measure: Pharmacokinetics/dynamics
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trials Center
Study officials:
affiliation: Seoul National University Hospital, Clinical Trials Center/Clinical Research Institute
name: Kyung-Sang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: