HealthyPhase 1PDF inhibitorNCT01904318
A Phase I Study of IDP-73152 Mesylate in Health Male Volunteer
A Phase 1 study testing IDP-73152 mesylate 40 mg, IDP-73152 mesylate 80 mg and IDP-73152 mesylate 160 mg in people with Healthy, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
A dose block-randomized, double-blinded, placebo-controlled, single dose, dose-escalation clinical phase I study to evaluate the safety, pharmacokinetics and food effect of IDP-73152 mesylate after oral administration in healthy male volunteer Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IDP-73152 mesylate 40 mg, IDP-73152 mesylate 80 mg and IDP-73152 mesylate 160 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Jan 2014
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 20-50 years inclusive, at screening visit.
- 55kg ≤ Body weight ≤90kg and body mass index (BMI) between 18.0 - 25.0 kg/m2.
- Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
- Subject was determined eligible according to the results of clinical laboratory tests like serum test, hematologic test, blood chemistry test, urine test etc. and vital signs, electrocardiography, physical exam etc. performed during the screening exam.
- Subject decided to participate voluntarily and gave written Informed consent to comply with the instructions after listening to and fully understanding the detailed explanation about this trial.
Who cannot join
- Subject has clinically significant liver, kidney, neurologic, immunologic, respiratory, endocrine disease or hematologic•oncologic disease, cardiovascular disease or psychiatric disease (mood disorder, compulsive disorder etc.) or such medical history (including subject with hepatitis virus in case of liver disease).
- Subject has history of gastrointestinal disease (such as Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or gastrointestinal surgery (except simple appendectomy or hernia operation) that can affect the absorption of the study drug.
- Subject has hypersensitivity reaction to drug (aspirin, antibiotics etc.) or history of clinically significant hypersensitivity reaction.
- Specific laboratory values at screening including: AST(SGOT) and/or ALT > 1.25 times the upper limit of normal; QTc > 430 ms or clinical significance of abnormal electrocardiographic patterns.
- Uncontrolled hypertension defined as sustained systolic blood pressure (SBP) < 90 mmHg or > 150 mmHg or diastolic BP (DBP) < 60 mmHg or > 110 mmHg at screening evaluation.
- History of recent tobacco abuse in the past 3 months.
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- Subject took any prescribed drug or oriental medicine within 2 weeks prior to the first medication or any over-the-counter (OTC) drug or vitamins within 1 week prior to the first medication (however, the subject can be included if other criteria are met according to the discretion of the investigator).
- Use of an investigational drug or treatment in past 2months
- Subject donated whole blood within 2 months prior to the first medication or apheresis within 1 month prior to the first medication or received blood transfusion within 1 month prior to the first medication.
- Subject continually drinks (in excess of 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from drinking through the study period.
- History of recent tobacco abuse (within 3 months)
- Subject took grapefruit/caffeine-containing food within 3 days prior to the first medication, or cannot abstain from taking during the hospitalization period.
- Subject was judged not to be eligible according to the discretion of the investigator for other reasons.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Jongno-gu, Seoul, 110-744
About this study
Official title: A Dose Block-randomized, Doubled, Placebo-controlled, Single Dose, Dose-escalation Clinical Phase I Study to Evaluate the Safety, Pharmacokinetics and Food
A dose block-randomized, double-blinded, placebo-controlled, single dose, dose-escalation clinical phase I study to evaluate the safety, pharmacokinetics and food effect of IDP-73152 mesylate after oral administration in healthy male volunteer
- Conditions
- Healthy
- Being tested
- IDP-73152 mesylate 40 mg, IDP-73152 mesylate 80 mg, IDP-73152 mesylate 160 mg, IDP-73152 mesylate 320 mg, IDP-73152 mesylate 640 mg
- Keywords
- male, Phase I, A dose block-randomized, Double-blinded, Placebo controlled, Single Dose, dose Escalation, IDP-73152 mesylate, Food Effect, Pharmacokinetics, health male volunteer, PDF inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-73152 mesylate 40 mgDrug
IDP-73152 mesylate 40 mg single dose administration
IDP-73152 mesylate 80 mgDrug
IDP-73152 mesylate 80 mg single dose administration
IDP-73152 mesylate 160 mgDrug
IDP-73152 mesylate 160 mg single dose administration
IDP-73152 mesylate 320 mgDrug
IDP-73152 mesylate 320 mg single dose administration
IDP-73152 mesylate 640 mgDrug
IDP-73152 mesylate 640 mg single dose administration
IDP-73152 mesylate 1280 mgDrug
IDP-73152 mesylate 1280 mg single dose administration
PlaceboDrug
Placebo single dose administration
| Study group | Role | What they receive |
|---|---|---|
| IDP-73152 mesylate 40 mg | Experimental | Not described Receives: Drug: IDP-73152 mesylate 40 mg |
| IDP-73152 mesylate 80 mg | Experimental | Not described Receives: Drug: IDP-73152 mesylate 80 mg |
| IDP-73152 mesylate 160 mg | Experimental | Not described Receives: Drug: IDP-73152 mesylate 160 mg |
| IDP-73152 mesylate 320 mg | Experimental | Not described Receives: Drug: IDP-73152 mesylate 320 mg |
| IDP-73152 mesylate 640 mg | Experimental | Not described Receives: Drug: IDP-73152 mesylate 640 mg |
| IDP-73152 mesylate 1280 mg | Experimental | Not described Receives: Drug: IDP-73152 mesylate 1280 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs
Measured: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Electrocardiography
Measured: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Clinical laboratory tests
Measured: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Physical exam
Measured: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 day
Adverse event
Measured: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Secondary outcomes (2)
Cmax, Cmax/D, AUClast, AUClast/D, AUCinf, AUCinf/D of IDP-73152 mesylate
Measured: Pre-dose (0 h), Post-dose (0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10,12, 24, 36, 48 h)
Tmax, T1/2, CL/F, CLr of IDP-73152 mesylate
Measured: Pre-dose (0 h), Post-dose (0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10,12, 24, 36, 48 h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionJan 2014
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyoung Sang you, MD, PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904318
- Sponsor's protocol ID
- ID-PDF-70-1
- Acronym
- PDF inhibitor
- Status last verified
- Feb 2014
- First submitted
- 16 Jul 2013
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Block-randomized, Doubled, Placebo-controlled, Single Dose, Dose-escalation Clinical Phase I Study to Evaluate the Safety, Pharmacokinetics and Food
- ClinicalTrials.gov ID
- NCT01904318
- Acronym / sponsor ID
- PDF inhibitor / ID-PDF-70-1
- Conditions
- Healthy
- Keywords
- male, Phase I, A dose block-randomized, Double-blinded, Placebo controlled, Single Dose, dose Escalation, IDP-73152 mesylate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Jul 2013 (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.
A dose block-randomized, double-blinded, placebo-controlled, single dose, dose-escalation clinical phase I study to evaluate the safety, pharmacokinetics and food effect of IDP-73152 mesylate after oral administration in healthy male volunteer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| IDP-73152 mesylate 40 mg | Experimental | Drug: IDP-73152 mesylate 40 mg |
| IDP-73152 mesylate 80 mg | Experimental | Drug: IDP-73152 mesylate 80 mg |
| IDP-73152 mesylate 160 mg | Experimental | Drug: IDP-73152 mesylate 160 mg |
| IDP-73152 mesylate 320 mg | Experimental | Drug: IDP-73152 mesylate 320 mg |
| IDP-73152 mesylate 640 mg | Experimental | Drug: IDP-73152 mesylate 640 mg |
| IDP-73152 mesylate 1280 mg | Experimental | Drug: IDP-73152 mesylate 1280 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 20-50 years inclusive, at screening visit.
- 55kg ≤ Body weight ≤90kg and body mass index (BMI) between 18.0 - 25.0 kg/m2.
- Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
- Subject was determined eligible according to the results of clinical laboratory tests like serum test, hematologic test, blood chemistry test, urine test etc. and vital signs, electrocardiography, physical exam etc. performed during the screening exam.
- Subject decided to participate voluntarily and gave written Informed consent to comply with the instructions after listening to and fully understanding the detailed explanation about this trial.
Key exclusion criteria (13 listed)
- Subject has clinically significant liver, kidney, neurologic, immunologic, respiratory, endocrine disease or hematologic•oncologic disease, cardiovascular disease or psychiatric disease (mood disorder, compulsive disorder etc.) or such medical history (including subject with hepatitis virus in case of liver disease).
- Subject has history of gastrointestinal disease (such as Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or gastrointestinal surgery (except simple appendectomy or hernia operation) that can affect the absorption of the study drug.
- Subject has hypersensitivity reaction to drug (aspirin, antibiotics etc.) or history of clinically significant hypersensitivity reaction.
- Specific laboratory values at screening including: AST(SGOT) and/or ALT > 1.25 times the upper limit of normal; QTc > 430 ms or clinical significance of abnormal electrocardiographic patterns.
- Uncontrolled hypertension defined as sustained systolic blood pressure (SBP) < 90 mmHg or > 150 mmHg or diastolic BP (DBP) < 60 mmHg or > 110 mmHg at screening evaluation.
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 |
|---|---|---|
| IDP-73152 mesylate 40 mgIDP-73152 mesylate 40 mg single dose administration | Drug | IDP-73152 mesylate 40 mg |
| IDP-73152 mesylate 80 mgIDP-73152 mesylate 80 mg single dose administration | Drug | IDP-73152 mesylate 80 mg |
| IDP-73152 mesylate 160 mgIDP-73152 mesylate 160 mg single dose administration | Drug | IDP-73152 mesylate 160 mg |
| IDP-73152 mesylate 320 mgIDP-73152 mesylate 320 mg single dose administration | Drug | IDP-73152 mesylate 320 mg |
| IDP-73152 mesylate 640 mgIDP-73152 mesylate 640 mg single dose administration | Drug | IDP-73152 mesylate 640 mg |
| IDP-73152 mesylate 1280 mgIDP-73152 mesylate 1280 mg single dose administration | Drug | IDP-73152 mesylate 1280 mg |
| PlaceboPlacebo single dose administration | Drug | Placebo |
Primary outcome
Vital signs
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Electrocardiography
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Clinical laboratory tests
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Physical exam
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 day
Adverse event
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
2 secondary outcomes
Cmax, Cmax/D, AUClast, AUClast/D, AUCinf, AUCinf/D of IDP-73152 mesylate
Time frame: Pre-dose (0 h), Post-dose (0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10,12, 24, 36, 48 h)
Tmax, T1/2, CL/F, CLr of IDP-73152 mesylate
Time frame: Pre-dose (0 h), Post-dose (0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10,12, 24, 36, 48 h)
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 12 Feb 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.
Kyoung Sang you, MD, PhD. principal investigator
Seoul National University Hospital
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 IDP-73152 mesylate 40 mg, IDP-73152 mesylate 80 mg and IDP-73152 mesylate 160 mg in people with Healthy, run by IlDong Pharmaceutical Co Ltd 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 5 inclusion and 13 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 12 Feb 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. Some participants in this study may receive a placebo. 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?
Vital signs (time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days). The study lists 5 primary outcomes in all. 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 12 Feb 2014.