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A Phase I Study of IDP-73152 Mesylate in Health Male Volunteer (PDF inhibitor)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904318
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Drug: IDP-73152 mesylate 40 mg Drug: IDP-73152 mesylate 80 mg Drug: IDP-73152 mesylate 160 mg Drug: IDP-73152 mesylate 320 mg Drug: IDP-73152 mesylate 640 mg Drug: IDP-73152 mesylate 1280 mg Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Dose Block-randomized, Doubled, Placebo-controlled, Single Dose, Dose-escalation Clinical Phase I Study to Evaluate the Safety, Pharmacokinetics and Food
Study Start Date : July 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: IDP-73152 mesylate 40 mg Drug: IDP-73152 mesylate 40 mg
IDP-73152 mesylate 40 mg single dose administration

Experimental: IDP-73152 mesylate 80 mg Drug: IDP-73152 mesylate 80 mg
IDP-73152 mesylate 80 mg single dose administration

Experimental: IDP-73152 mesylate 160 mg Drug: IDP-73152 mesylate 160 mg
IDP-73152 mesylate 160 mg single dose administration

Experimental: IDP-73152 mesylate 320 mg Drug: IDP-73152 mesylate 320 mg
IDP-73152 mesylate 320 mg single dose administration

Experimental: IDP-73152 mesylate 640 mg Drug: IDP-73152 mesylate 640 mg
IDP-73152 mesylate 640 mg single dose administration

Experimental: IDP-73152 mesylate 1280 mg Drug: IDP-73152 mesylate 1280 mg
IDP-73152 mesylate 1280 mg single dose administration

Placebo Comparator: Placebo Drug: Placebo
Placebo single dose administration




Primary Outcome Measures :
  1. Vital signs [ Time Frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days ]
  2. Electrocardiography [ Time Frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days ]
  3. 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 ]
  4. Physical exam [ Time Frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 day ]
  5. Adverse event [ Time Frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904318


Locations
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Korea, Republic of
Seoul National University Hospital
Jongno-gu, Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd
Investigators
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Principal Investigator: Kyoung Sang you, MD, PhD. Seoul National University Hospital
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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT01904318    
Other Study ID Numbers: ID-PDF-70-1
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014
Keywords provided by IlDong Pharmaceutical Co Ltd:
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