Clinical trial NCT01904318: A Phase I Study of IDP-73152 Mesylate in Health Male Volunteer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
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
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2013-07-22
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Vital signs
timeFrame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
measure: Electrocardiography
timeFrame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
measure: Clinical laboratory tests
timeFrame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
measure: Physical exam
timeFrame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 day
measure: Adverse event
timeFrame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Secondary outcomes:
measure: Cmax, Cmax/D, AUClast, AUClast/D, AUCinf, AUCinf/D of IDP-73152 mesylate
timeFrame: 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)
measure: Tmax, T1/2, CL/F, CLr of IDP-73152 mesylate
timeFrame: 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)
Other outcomes:
Locations:
city: Jongno-gu
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul
Study officials:
affiliation: Seoul National University Hospital
name: Kyoung Sang you, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: