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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; 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

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Jongno-gu, Seoul, Korea, Republic of, 110-744
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo single dose administration
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vital signs	participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Electrocardiography	participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Clinical laboratory tests	participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Physical exam	participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 day
Adverse event	participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax, Cmax/D, AUClast, AUClast/D, AUCinf, AUCinf/D of IDP-73152 mesylate	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	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)

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd
• Investigators: Principal Investigator: Kyoung Sang you, MD, PhD., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 16, 2013
• First Submitted That Met QC Criteria: July 17, 2013
• First Posted (Estimate): July 22, 2013

Study Record Updates

• Last Update Posted (Estimate): February 12, 2014
• Last Update Submitted That Met QC Criteria: February 11, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Pharmacokinetics; male; Phase I; Placebo controlled; Food Effect; Single Dose; Double-blinded; A dose block-randomized; dose Escalation; IDP-73152 mesylate; health male volunteer; PDF inhibitor
• Other Study ID Numbers: ID-PDF-70-1