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

April 20, 2016 updated by: Amorepacific Corporation

A Randomized, Double-blind, Placebo-controlled Multiple Dosing Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of PAC-14028 Cream After Transdermal Administration in Healthy Volunteers

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital Clinical Trials Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)
  3. 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 within 1 week before the study drug initiation (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.)
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: placebo
vehicle cream, dermal administration, multiple dosing
Other: Vehicle
Participants will receive vehicle cream applied topically once a day for 9 days
Other Names:
  • Vehicle cream
Experimental: drug
PAC-14028 cream, dermal administration, multiple dosing, dose escalation
Drug: PAC-14028
Participants will receive PAC-14028 cream applied topically once a day for 9 days
Other Names:
  • PAC-14028 cream 0.1%
  • PAC-14028 cream 0.3%
  • PAC-14028 cream 1.0%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety/Tolerability (adverse events, abnormal vital signs, ECG test, clinical lab tests, Numerical pain recording scale)
Time Frame: Day 1~9, at specified time for each tests
AE incidence pattern, abnormal findings in vital sign, ECG test, and clinical lab tests, Numerical pain recording scale
Day 1~9, at specified time for each tests

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (Concentration of PAC-14028 in Blood; Cmax, AUC)
Time Frame: Day 1: 0 ~ 16h ; Day 2~8: 0h ; Day 9: 0 ~ 96h
Concentration of PAC-14028 in Blood; Cmax, AUC
Day 1: 0 ~ 16h ; Day 2~8: 0h ; Day 9: 0 ~ 96h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amorepacific Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AP-TRPV1-PI-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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