PAC-14028 in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amorepacific Corporation
ClinicalTrials.gov Identifier:
NCT01264224
First received: December 20, 2010
Last updated: January 19, 2014
Last verified: January 2014
  Purpose
  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.

Condition Intervention Phase
Healthy
Drug: PAC-14028
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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.

Further study details as provided by Amorepacific Corporation:

Primary Outcome Measures:
  • Safety/Tolerability [ Designated as safety issue: Yes ]
    AE incidence pattern, abnormal findings in vital sign, ECG test, and clinical lab tests


Secondary Outcome Measures:
  • Pharmacokinetics/dynamics [ Designated as safety issue: No ]
    • PK:Concentration of PAC-14028 in Blood and Urine; Cmax, AUC
    • PD:Heat pain threshold/tolerance


Enrollment: 60
Study Start Date: December 2010
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PAC-14028 Drug: PAC-14028
tablets, oral administration, single/multiple dosing, dose escalation

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264224

Locations
Korea, Republic of
Seoul National University Hospital Clinical Trials Center
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Amorepacific Corporation
Investigators
Principal Investigator: Kyung-Sang Yu, M.D., Ph.D. Seoul National University Hospital, Clinical Trials Center/Clinical Research Institute
  More Information

No publications provided

Responsible Party: Amorepacific Corporation
ClinicalTrials.gov Identifier: NCT01264224     History of Changes
Other Study ID Numbers: AP-TRPV1-PI-01
Study First Received: December 20, 2010
Last Updated: January 19, 2014
Health Authority: Republic of Korea: Korea Food and Drug Administration

ClinicalTrials.gov processed this record on April 16, 2014