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

December 20, 2010
January 19, 2014
December 2010
June 2012   (final data collection date for primary outcome measure)
Safety/Tolerability [ Designated as safety issue: Yes ]
AE incidence pattern, abnormal findings in vital sign, ECG test, and clinical lab tests
Same as current
Complete list of historical versions of study NCT01264224 on ClinicalTrials.gov Archive Site
Pharmacokinetics/dynamics [ Designated as safety issue: No ]
  • PK:Concentration of PAC-14028 in Blood and Urine; Cmax, AUC
  • PD:Heat pain threshold/tolerance
Same as current
Not Provided
Not Provided
 
PAC-14028 in Healthy Male Volunteers
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.
  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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Healthy
Drug: PAC-14028
tablets, oral administration, single/multiple dosing, dose escalation
Experimental: PAC-14028
Intervention: Drug: PAC-14028
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
June 2012   (final data collection date for primary outcome measure)

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.
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01264224
AP-TRPV1-PI-01
No
Amorepacific Corporation
Amorepacific Corporation
Not Provided
Principal Investigator: Kyung-Sang Yu, M.D., Ph.D. Seoul National University Hospital, Clinical Trials Center/Clinical Research Institute
Amorepacific Corporation
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP