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Completed

NCT Number: NCT02309008

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

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

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Key information

Conditions

Age range

19 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital Clinical Trials Center

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men aged 19 to 65 years at the time of screening
  • 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
  • Who doesn't have skin disease, skin damage (including tatoos or scars), or excessive hair in application area which can affect drug absorption
  • 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

  • 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
  • Who has a history of hypersensitivity or allergies to any drug (aspirin, antibiotics, etc)
  • 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.)
  • Who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine)
  • 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)
  • Who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)
  • Who consistently consumes alcohol
  • 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.)
  • Who has had bleeding or blood collection and donation over 400 mL within 8 weeks before study drug administration
  • 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
  • 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)
  • Who is determined ineligible for study participation by investigators for any reason including clinical lab test and ECG results.

Treatment and study plan

PAC-14028

Drug

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%

Vehicle

Other

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

Other names: Vehicle cream

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Collaborators

  • Seoul National University Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
First posted
Dec 5, 2014
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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