A Study to Assess the Safety, Tolerability and Pharmacokinetics of PAC-14028 Cream in Healthy Male Subjects

NCT ID: NCT02309008

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30

Brief Summary

The purpose of this study is to investigate the safety/tolerability and pharmacokinetics of PAC-14028 cream after transdermal administration in healthy male volunteers.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

placebo

vehicle cream, dermal administration, multiple dosing

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: OTHER

Participants will receive vehicle cream applied topically once a day for 9 days

drug

PAC-14028 cream, dermal administration, multiple dosing, dose escalation

Group Type: EXPERIMENTAL

PAC-14028

Intervention Type: DRUG

Participants will receive PAC-14028 cream applied topically once a day for 9 days

Interventions

PAC-14028

Participants will receive PAC-14028 cream applied topically once a day for 9 days

Intervention Type: DRUG

Vehicle

Participants will receive vehicle cream applied topically once a day for 9 days

Intervention Type: OTHER

Other Intervention Names

PAC-14028 cream 0.1%; PAC-14028 cream 0.3%; PAC-14028 cream 1.0%; Vehicle cream

Eligibility Criteria

Inclusion Criteria

1. Healthy men aged 19 to 65 years at the time of screening

2. Whose weight is 50 kg or more, but less than 90 kg, and whose body mass index (BMI) is 18.0 kg/m^2 or more but less than 27 kg/m^2

• BMI (kg/m^2) = weight(kg) /{height(m)}^2

3. Who doesn't have skin disease, skin damage (including tatoos or scars), or excessive hair in application area which can affect drug absorption

4. 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,skin, psychical disorders or blood tumor

2. Who has a history of hypersensitivity or allergies to any drug (aspirin, antibiotics, etc)

4. Who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine)

5. Who has smoked within 3 months before study drug administration (Smoker who has stopped smoking for more than 3 months before study drug administration is eligible to participate)

6. Who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)

7. Who consistently consumes alcohol

8. Who has participated in other clinical study within 8 weeks before study drug administration (however, the last dosing day is considered as the end of clinical study.)

9. Who has had bleeding or blood collection and donation over 400 mL within 8 weeks before study drug administration

10. Who donated whole blood within 2 months before study drug administration, who donated via plasmapheresis/plateletpheresis within 1 month before study drug administration, or who received a blood transfusion within 1 month before study drug administration

11. Whose vital sign measured at sitting position after resting at least 3 minutes is as following

• Low blood pressure (Systolic pressure: less than 90 mmHg, Diastolic pressure: less than 60 mmHg)
• High blood pressure (Systolic pressure: higher than 150 mmHg, Diastolic pressure: higher than 100 mmHg)

12. Who is determined ineligible for study participation by investigators for any reason including clinical lab test and ECG results.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Amorepacific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital Clinical Trials Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AP-TRPV1-PI-03

Identifier Type: -

Identifier Source: org_study_id