HealthyPhase 1NCT01264224
PAC-14028 in Healthy Male Volunteers
A Phase 1 study testing PAC-14028 in people with Healthy, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PAC-14028
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men aged 20 to 45 years at the time of screening
- 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
- 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.
Who cannot join
- 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
- Who has gastrointestinal diseases or operation history which may interfere study drug absorption (however, except simple appendectomy and hernioplasty )
- 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 (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)
- Smoker or who has stopped smoking within previous 1 month or shows positive result at cotinine test.
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- Who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)
- Who consistently consumes alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol)
- 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.)
- Who has had bleeding or blood collection and donation over 400 mL within 12 weeks before study drug administration
- 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)
- Who is determined ineligible for study participation by investigators for any reason including clinical lab test and ECG results.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trials Center
Seoul, 110-744
About this study
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.
- Primary Objective:
- To evaluate safety and tolerability of single and multiple oral dosing of PAC-14028 in healthy male volunteers.
- Secondary Objective:
- To evaluate pharmacokinetics and pharmacodynamics of single and multiple oral dosing of PAC-14028 in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- PAC-14028
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAC-14028Drug
tablets, oral administration, single/multiple dosing, dose escalation
| Study group | Role | What they receive |
|---|---|---|
| PAC-14028 | Experimental | Not described Receives: Drug: PAC-14028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Tolerability
AE incidence pattern, abnormal findings in vital sign, ECG test, and clinical lab tests
Secondary outcomes (1)
Pharmacokinetics/dynamics
- PK:Concentration of PAC-14028 in Blood and Urine; Cmax, AUC
- PD:Heat pain threshold/tolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, M.D., Ph.D., Principal investigator, Seoul National University Hospital, Clinical Trials Center/Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264224
- Sponsor's protocol ID
- AP-TRPV1-PI-01
- Status last verified
- Jan 2014
- First submitted
- 20 Dec 2010
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01264224
- Acronym / sponsor ID
- AP-TRPV1-PI-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jun 2012 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Primary Objective:
- To evaluate safety and tolerability of single and multiple oral dosing of PAC-14028 in healthy male volunteers.
- Secondary Objective:
- To evaluate pharmacokinetics and pharmacodynamics of single and multiple oral dosing of PAC-14028 in healthy male volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAC-14028 | Experimental | Drug: PAC-14028 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men aged 20 to 45 years at the time of screening
- 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
- 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.
Key exclusion criteria (14 listed)
- 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
- Who has gastrointestinal diseases or operation history which may interfere study drug absorption (however, except simple appendectomy and hernioplasty )
- 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 (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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAC-14028tablets, oral administration, single/multiple dosing, dose escalation | Drug | PAC-14028 |
Primary outcome
Safety/Tolerability
AE incidence pattern, abnormal findings in vital sign, ECG test, and clinical lab tests
1 secondary outcome
Pharmacokinetics/dynamics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Sang Yu, M.D., Ph.D. principal investigator
Seoul National University Hospital, Clinical Trials Center/Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PAC-14028 in people with Healthy, run by Amorepacific Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/Tolerability. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.